Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods

ABSTRACT

Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an anchoring member having a first portion configured to engage with tissue on or near the annulus of the native heart valve and to deform in a non-circular shape to conform to the tissue. The device can also include a valve support coupled to a second portion of the anchoring member, configured to support a prosthetic valve and having a cross-sectional shape. In some embodiments, the first portion of the anchoring member is mechanically isolated from the valve support such that the cross-sectional shape of the valve support remains sufficiently stable that the prosthetic valve remains competent when the anchoring member is deformed in the non-circular shape.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application claims priority to U.S. Provisional PatentApplication No. 61/605,699, filed Mar. 1, 2012, entitled “SYSTEM FORMITRAL VALVE REPLACEMENT,” to U.S. Provisional Patent Application No.61/549,044, filed Oct. 19, 2011, entitled “CONFORMABLE SYSTEM FOR MITRALVALVE REPLACEMENT,” both of which are incorporated herein in theirentireties by reference. The present application incorporates thesubject matter of (1) International PCT Patent Application No.PCT/US2012/043636, entitled “PROSTHETIC HEART VALVE DEVICES ANDASSOCIATED SYSTEMS AND METHODS,” filed Jun. 21, 2012; (2) U.S.Provisional Patent Application No. 61/549,037, entitled “SYSTEM FORMITRAL VALVE REPLACEMENT,” filed Oct. 19, 2011; and (3) InternationalPCT Patent Application No. ______, (Attorney Docket NO. 82829-8005WO00),entitled “DEVICES, SYSTEMS AND METHODS FOR HEART VALVE REPLACEMENT,”filed Oct. 19, 2012, in their entireties by reference.

TECHNICAL FIELD

The present technology relates generally to prosthetic heart valvedevices. In particular, several embodiments are directed to prostheticmitral valves and devices for percutaneous repair and/or replacement ofnative mitral valves and associated systems and methods.

BACKGROUND

Conditions affecting the proper functioning of the mitral valve include,for example, mitral valve regurgitation, mitral valve prolapse andmitral valve stenosis. Mitral valve regurgitation is a disorder of theheart in which the leaflets of the mitral valve fail to coapt intoapposition at peak contraction pressures, resulting in abnormal leakingof blood from the left ventricle into the left atrium. There are anumber of structural factors that may affect the proper closure of themitral valve leaflets. For example, many patients suffering from heartdisease experience dilation of the heart muscle, resulting in anenlarged mitral annulus. Enlargement of the mitral annulus makes itdifficult for the leaflets to coapt during systole. A stretch or tear inthe chordae tendineae, the tendons connecting the papillary muscles tothe inferior side of the mitral valve leaflets, may also affect properclosure of the mitral annulus. A ruptured chordae tendineae, forexample, may cause a valve leaflet to prolapse into the left atrium dueto inadequate tension on the leaflet. Abnormal backflow can also occurwhen the functioning of the papillary muscles is compromised, forexample, due to ischemia. As the left ventricle contracts duringsystole, the affected papillary muscles do not contract sufficiently toeffect proper closure.

Mitral valve prolapse, or when the mitral leaflets bulge abnormally upin to the left atrium, causes irregular behavior of the mitral valve andmay also lead to mitral valve regurgitation. Normal functioning of themitral valve may also be affected by mitral valve stenosis, or anarrowing of the mitral valve orifice, which causes impedance of fillingof the left ventricle in diastole.

Typically, treatment for mitral valve regurgitation has involved theapplication of diuretics and/or vasodilators to reduce the amount ofblood flowing back into the left atrium. Other procedures have involvedsurgical approaches (open and intravascular) for either the repair orreplacement of the valve. For example, typical repair approaches haveinvolved cinching or resecting portions of the dilated annulus.

Cinching of the annulus has been accomplished by the implantation ofannular or peri-annular rings which are generally secured to the annulusor surrounding tissue. Other repair procedures have also involvedsuturing or clipping of the valve leaflets into partial apposition withone another.

Alternatively, more invasive procedures have involved the replacement ofthe entire valve itself where mechanical valves or biological tissue areimplanted into the heart in place of the mitral valve. These invasiveprocedures are conventionally done through large open thoracotomies andare thus very painful, have significant morbidity, and require longrecovery periods.

However, with many repair and replacement procedures, the durability ofthe devices or improper sizing of annuloplasty rings or replacementvalves may result in additional problems for the patient. Moreover, manyof the repair procedures are highly dependent upon the skill of thecardiac surgeon where poorly or inaccurately placed sutures may affectthe success of procedures.

Less invasive approaches to aortic valve replacement have been developedin recent years. Examples of pre-assembled, percutaneous prostheticvalves include, e.g., the CoreValve Revalving® System fromMedtronic/Corevalve Inc. (Irvine, Calif., USA) and the Edwards-Sapien®Valve from Edwards Lifesciences (Irvine, Calif., USA). Both valvesystems include an expandable frame housing a tri-leaflet bioprostheticvalve. The frame is expanded to fit the substantially symmetric,circular and rigid aortic annulus. This gives the expandable frame inthe delivery configuration a symmetric, circular shape at the aorticvalve annulus, suitable to supporting a tri-leaflet prosthetic valve(which requires such symmetry for proper coaptation of the prostheticleaflets). Thus, aortic valve anatomy lends itself to an expandableframe housing a replacement valve since the aortic valve anatomy issubstantially uniform, symmetric, and fairly rigid.

Mitral valve replacement, compared with aortic valve replacement, posesunique anatomical obstacles, rendering percutaneous mitral valvereplacement significantly more challenging than aortic valvereplacement. First, unlike the relatively symmetric and uniform aorticvalve, the mitral valve annulus has a non-circular D-shape orkidney-like shape, with a non-planar, saddle-like geometry often lackingsymmetry. Such unpredictability makes it difficult to design a mitralvalve prosthesis having the ability to conform to the mitral annulus.Lack of a snug fit between the prosthesis and the native leaflets and/orannulus may leave gaps therein, creating backflow of blood through thesegaps. Placement of a cylindrical valve prosthesis, for example, mayleave gaps in commissural regions of the native valve, potentiallyresulting in perivalvular leaks in those regions.

Current prosthetic valves developed for percutaneous aortic valvereplacement are unsuitable for adaptation to the mitral valve. First,many of these devices require a direct, structural connection betweenthe device structure which contacts the annulus and/or leaflets and thedevice structure which supports the prosthetic valve. In severaldevices, the same stent posts which support the prosthetic valve alsocontact the annulus or other surrounding tissue, directly transferringto the device many of the distorting forces exerted by the tissue andblood as the heart contracts during each cardiac cycle. Most cardiacreplacement devices further utilize a tri-leaflet valve, which requiresa substantially symmetric, cylindrical support around the prostheticvalve for proper opening and closing of the three leaflets over years oflife. If these devices are subject to movement and forces from theannulus and other surrounding tissues, the prostheses may be compressedand/or distorted causing the prosthetic leaflets to malfunction.Moreover, the typical diseased mitral annulus is much larger than anyavailable prosthetic valve.

In addition to its irregular, unpredictable shape, the mitral valveannulus lacks a significant amount of radial support from surroundingtissue. The aortic valve, for example, is completely surrounded byfibro-elastic tissue, helping to anchor a prosthetic valve by providingnative structural support. The mitral valve, on the other hand, is boundby muscular tissue on the outer wall only. The inner wall of the mitralvalve is bound by a thin vessel wall separating the mitral valve annulusfrom the inferior portion of the aortic outflow tract. As a result,significant radial forces on the mitral annulus, such as those impartedby an expanding stent prostheses, could lead to collapse of the inferiorportion of the aortic tract with potentially fatal consequences.

The chordae tendineae of the left ventricle may also present an obstaclein deploying a mitral valve prosthesis. This is unique to the mitralvalve since aortic valve anatomy does not include chordae. The maze ofchordae in the left ventricle makes navigating and positioning adeployment catheter that much more difficult in mitral valve replacementand repair. Deployment and positioning of a prosthetic valve oranchoring device on the ventricular side of the native mitral valve isfurther complicated by the presence of the chordae.

Given the difficulties associated with current procedures, there remainsthe need for simple, effective, and less invasive devices and methodsfor treating dysfunctional heart valves.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present disclosure can be better understood withreference to the following drawings. The components in the drawings arenot necessarily to scale. Instead, emphasis is placed on illustratingclearly the principles of the present disclosure. Furthermore,components can be shown as transparent in certain views for clarity ofillustration only and not to indicate that the illustrated component isnecessarily transparent.

FIGS. 1 and 2 are schematic illustrations of a mammalian heart havingnative valve structures suitable for replacement with various prostheticheart valve devices in accordance with embodiments of the presenttechnology.

FIG. 3 is a schematic cross-sectional side view of a native mitral valveshowing the annulus and leaflets.

FIG. 4A is a schematic illustration of the left ventricle of a hearthaving either i) prolapsed leaflets in the mitral valve, or ii) mitralvalve regurgitation in the left ventricle of a heart having impairedpapillary muscles, and which are suitable for combination with variousprosthetic heart valve devices in accordance with embodiments of thepresent technology.

FIG. 4B is a schematic illustration of a heart in a patient sufferingfrom cardiomyopathy, and which is suitable for combination with variousprosthetic heart valve devices in accordance with embodiments of thepresent technology.

FIG. 5A is a schematic illustration of a native mitral valve of a heartshowing normal closure of native mitral valve leaflets.

FIG. 5B is a schematic illustration of a native mitral valve of a heartshowing abnormal closure of native mitral valve leaflets in a dilatedheart, and which is suitable for combination with various prostheticheart valve devices in accordance with embodiments of the presenttechnology.

FIG. 5C is a schematic illustration of a mitral valve of a heart showingdimensions of the annulus, and which is suitable for combination withvarious prosthetic heart valve devices in accordance with embodiments ofthe present technology.

FIG. 6A is a schematic, cross-sectional illustration of the heartshowing an antegrade approach to the native mitral valve from the venousvasculature, in accordance with various embodiments of the presenttechnology.

FIG. 6B is a schematic, cross-sectional illustration of the heartshowing access through the inter-atrial septum (IAS) maintained by theplacement of a guide catheter over a guidewire, in accordance withvarious embodiments of the present technology.

FIGS. 7 and 8 are schematic, cross-sectional illustrations of the heartshowing retrograde approaches to the native mitral valve through theaortic valve and arterial vasculature, in accordance with variousembodiments of the present technology.

FIG. 9 is a schematic, cross-sectional illustration of the heart showingan approach to the native mitral valve using a trans-apical puncture inaccordance with various embodiments of the present technology.

FIG. 10A shows an isometric view of a prosthetic heart valve device inaccordance with an embodiment of the present technology.

FIG. 10B illustrates a cut-away view of a heart showing the prosthetictreatment device of FIG. 10A implanted at a native mitral valve inaccordance with an embodiment of the present technology.

FIGS. 10C-10F are side, perspective cut-away, top, and bottom views,respectively, of a prosthetic heart valve device in accordance with anembodiment of the present technology.

FIG. 11A is a side view of a valve support in an expanded configurationin accordance with an embodiment of the present technology.

FIGS. 11B-11D are isometric views of additional embodiments of valvesupports with prosthetic valves mounted therein in accordance with thepresent technology.

FIG. 11E shows an isometric view of a prosthetic heart valve device inaccordance with another embodiment of the present technology.

FIGS. 12A-12C are side views of various longitudinal ribs flexing inresponse to a distorting force in accordance with further embodiments ofthe present technology.

FIG. 13A is a schematic, cross-sectional view of a prosthetic heartvalve device in accordance with another embodiment of the presenttechnology.

FIGS. 13B-13F are partial side views of prosthetic heart valve devicesillustrating a variety of longitudinal rib configurations in accordancewith additional embodiments of the present technology.

FIG. 14A is a schematic top view of a native mitral valve illustratingthe major and minor axes.

FIGS. 14B-14C are schematic top views of an anchoring member in anexpanded configuration and in a deployed configuration, respectively, inaccordance with an embodiment of the present technology.

FIG. 15 is an isometric view of a prosthetic heart valve deviceillustrated in a deployed configuration in accordance with an additionalembodiment of the present technology.

FIG. 16A is a top view of a prosthetic heart valve device illustrated inan expanded configuration in accordance with a further embodiment of thepresent technology.

FIGS. 16B-16C are a first side view and a second side view,respectively, of the prosthetic heart valve device of FIG. 16A.

FIG. 16D is a side view of a prosthetic heart valve device showing thelongitudinal axis of the anchoring member off-set from the longitudinalaxis of the valve support by a tilt angle in accordance with anotherembodiment of the present technology.

FIG. 16E is a schematic top view of a native mitral valve in the heartviewed from the left atrium and showing the prosthetic treatment deviceof FIG. 16A-16C implanted at the native mitral valve in accordance withan embodiment of the present technology.

FIGS. 17A-17C are schematic top and first and second side views of theprosthetic heart valve device of FIG. 16A showing dimensions and taperangles of various aspects of the device in accordance with embodimentsof the present technology.

FIG. 18 is an isometric view of an anchoring member illustrated in anexpanded configuration in accordance with yet another embodiment of thepresent technology.

FIGS. 19A-19C are isometric, side and top views, respectively, of aprosthetic heart valve device having a sealing member in accordance witha further embodiment of the present technology.

FIG. 20A is an isometric view of a prosthetic heart valve device withouta sealing member in accordance with an embodiment of the presenttechnology.

FIGS. 20B-20E are isometric views of prosthetic heart valve deviceshaving sealing members in accordance with additional embodiments of thepresent technology.

FIGS. 21A-21B are cross-sectional side and isometric views of aprosthetic heart valve device having a tubular valve support member inaccordance with a further embodiment of the present technology.

FIGS. 21C-21F are partial cross-sectional side views and an isometricview of prosthetic heart valve devices having a tubular valve supportmember in accordance with other embodiments of the present technology.

FIGS. 22A-22G and 22I-22K are enlarged side views of various mechanismsof coupling a valve support to an anchoring member in accordance withadditional embodiments of the present technology.

FIG. 22H is a side view of a post in the prosthetic heart valve deviceof FIG. 40G.

FIGS. 23A-23B are enlarged side views of a additional mechanisms forcoupling an anchoring member to a valve support member in accordancewith further embodiments of the present technology.

FIG. 24A is a perspective view of an integral connection between a valvesupport and an anchoring member in accordance with an additionalembodiment of the present technology.

FIGS. 24B-24D are enlarged views of additional embodiments of anintegral connection between a valve support and an anchoring member inaccordance with the present technology.

FIG. 25A is a partial cross-sectional view of a prosthetic heart valvedevice having an anchoring member and a valve support in accordance withan embodiment of the present technology.

FIG. 25B is an enlarged view of the designated box shown in FIG. 25A

FIGS. 26A-26D are schematic cross-sectional views of prosthetic heartvalve devices having atrial retainers and implanted at a native mitralvalve in accordance with various embodiments of the present technology.

FIG. 27 is a side view of an anchoring member having a vertical portionat the upstream end for engaging the annulus in accordance with anotherembodiment of the present technology.

FIG. 28 is a side view of a prosthetic heart valve device in an expandedconfiguration and having a plurality of stabilizing elements inaccordance with an embodiment of the present technology.

FIG. 29 is an enlarged schematic, side view of a prosthetic heart valvedevice having an extended arm in accordance with an embodiment of thepresent technology.

FIGS. 30A-30C are enlarged partial side views of a prosthetic heartvalve device having arms coupled to the device at various angles withrespect to a longitudinal axis of the device in accordance with furtherembodiments of the present technology.

FIGS. 31A-31C are enlarged, partial side views of a prosthetic heartvalve device having arms of various lengths coupled to the device inaccordance with additional embodiments of the present technology.

FIGS. 32A, 32B, 32C, and 32D are cross-sectional views of a heart withan implanted prosthetic heart valve device having arms disposed on aninward-facing surface of the leaflets in accordance with variousembodiments of the present technology.

FIGS. 32A-1, 32B-1, 32C-1 and 32D-1 are enlarged views of the armsengaging the inward-facing surface of the leaflets as shown in FIGS.32A, 32B, 32C and 32D, respectively in accordance with variousembodiments of the present technology.

FIGS. 33A-33C are schematic views illustrating various embodiments oftissue engaging elements for use with prosthetic heart valve devices inaccordance with the present technology.

FIGS. 34A, 34B and 34C are cross-sectional views of a heart with animplanted prosthetic heart valve device having arms with tissue engagingelements disposed on an inward-facing surface of the leaflets inaccordance with various embodiments of the present technology.

FIGS. 34A-1, 34B-1 and 34C-1 are enlarged views of the arms engaging theinward-facing surface of the leaflets as shown in FIGS. 34A, 34B and34C, respectively in accordance with various embodiments of the presenttechnology.

FIGS. 35A-35C are side views of prosthetic heart valve devices and shownimplanted at a mitral valve (illustrated in cross-section), the deviceshaving arms for engaging an outward-facing surface of the nativeleaflets in accordance with further embodiments of the presenttechnology.

FIG. 35C-1 is an enlarged view of the arm engaging the inward-facingsurface of the leaflets as shown in FIG. 35C in accordance with variousembodiments of the present technology.

FIG. 36A is a side view of a prosthetic heart valve device and shownimplanted at a mitral valve (illustrated in cross-section), the devicehaving arms for engaging an outward-facing surface of the nativeleaflets and arms for engaging an inward-facing surface of the nativeleaflets in accordance with an additional embodiment of the presenttechnology.

FIG. 36B is an enlarged view of the arms engaging the inward-facing andoutward-facing surfaces of the leaflets as shown in FIG. 36A.

FIGS. 37A-37D are enlarged side views of additional embodiments of armssuitable for use with a prosthetic heart valve device in accordance withthe present technology.

FIG. 38A is a side view of a prosthetic heart valve device having aplurality of non-interconnected arms in accordance with a furtherembodiment of the present technology.

FIG. 38B is a side view of a prosthetic heart valve device having aplurality of circumferentially connected arms in accordance with afurther embodiment of the present technology.

FIGS. 39A-39D are schematic top views of arm location patterns inaccordance with additional embodiments of the present technology.

FIGS. 40A-40D are side views of prosthetic heart valve devices havingtissue engaging elements on varying structures of the device inaccordance with additional embodiments of the present technology.

FIGS. 40E-40G are enlarged side views of tissue engaging elementssuitable for use with prosthetic heart valve devices in accordance withother embodiments of the present technology.

FIGS. 40I-40T are enlarged side views of embodiments of tissue engagingelements suitable for use with prosthetic heart valve devices inaccordance with additional embodiments of the present technology.

FIG. 41 is an isometric view of a prosthetic heart valve device having aplurality of annulus engaging elements in accordance with a furtherembodiment of the present technology.

FIGS. 42A-42B are cross-sectional side and enlarged views of aprosthetic heart valve device having tissue engaging elements deployablefrom a plurality of tubular ribs in accordance with another embodimentof the present technology.

FIGS. 43A-43B are an isometric view and an enlarged detail view of aprosthetic heart valve device having a sealing member configured withtissue engaging elements in accordance with another embodiment of thepresent technology

FIGS. 44A-44F are enlarged side views of embodiments of tissue engagingelements suitable for use with prosthetic heart valve devices inaccordance with additional embodiments of the present technology.

FIG. 45A is an isometric view of a prosthetic heart valve device havinga plurality of tethers between the anchoring member 110 and the valvesupport 120 in accordance with an embodiment of the present technology.

FIG. 45B is an isometric view of a prosthetic heart valve device havinga plurality of septa between the anchoring member 110 and the valvesupport 120 in accordance with another embodiment of the presenttechnology.

FIG. 46A is side partial cut-away view of a delivery system inaccordance with an embodiment of the present technology.

FIG. 46B is an enlarged cross-sectional view of a distal end of adelivery system in accordance with an embodiment of the presenttechnology.

FIGS. 46C-46D are enlarged partial side views of a valve supportconfigured for use with the delivery system of FIG. 46B in accordancewith an embodiment of the present technology.

FIGS. 47A-47D are cross-sectional views of a heart showing an antegradeor trans-septal approach to the mitral valve in accordance with anembodiment of the present technology.

FIGS. 48A-48C are cross-sectional views of the heart illustrating amethod of implanting a prosthetic heart valve device using atrans-septal approach in accordance with another embodiment of thepresent technology.

FIGS. 49A-49B are cross-sectional views of the heart showing aretrograde approach to the mitral valve via the aorta and left ventriclein accordance with a further embodiment of the present technology.

FIGS. 50A-50B are cross-sectional views of the heart illustrating afurther embodiment of a method of implanting the prosthetic heart valvedevice using a trans-apical approach in accordance with aspects of thepresent technology.

FIGS. 51A-51B are partial side views of a delivery system wherein aprosthetic heart valve device is mounted on an expandable balloon of adelivery catheter in accordance with another embodiment of the presenttechnology.

FIGS. 52A-52D are cross-sectional views of a heart showing a method ofdelivering a prosthetic heart valve device having a valve supportmovably coupled to an anchoring member in accordance with a furtherembodiment of the present technology.

FIGS. 53A-53D are partial side views showing various mechanisms formovably coupling the valve support to the anchoring member in accordancewith additional embodiments of the present technology.

FIG. 53E is a partial top view of the device of FIG. 53D.

FIG. 53F is a side view of an alternative mechanism for slideablycoupling a valve support and anchoring member in accordance with anotherembodiment of the present technology.

FIGS. 53G-53H are schematic side views of a prosthetic heart valvedevice showing yet another mechanism for coupling the valve support tothe anchoring member in accordance with a further embodiment of thepresent technology.

FIG. 54A is a cross-sectional side view of another embodiment of adelivery system for the prosthetic heart valve device in accordance withother aspects of the present technology.

FIG. 54B is a partial cross-sectional side view of a distal portion ofthe delivery system of FIG. 54A.

FIGS. 55A-55C are perspective views of the delivery system of FIG. 46illustrating the steps of delivering the prosthetic treatment device ofthe invention.

FIG. 56 is a side cross-sectional view of a further embodiment of adelivery system for the prosthetic treatment device of the invention.

FIGS. 57A-57D are isometric views of prosthetic treatment devices inaccordance with additional embodiments of the present technology.

FIG. 57E is a schematic cross-sectional view of the prosthetic heartvalve device of FIG. 57A implanted at a native mitral valve inaccordance with an embodiment of the present technology.

FIGS. 58A-58D are cross-sectional views of a heart showing a method ofdelivering a prosthetic heart valve device to a native mitral valve inthe heart using a trans-apical approach in accordance with anotherembodiment of the present technology.

FIGS. 59A-59C are isometric views of prosthetic treatment devices inaccordance with additional embodiments of the present technology.

FIG. 59D is a schematic cross-sectional view of a prosthetic heart valvedevice implanted at a native mitral valve in accordance with anotherembodiment of the present technology.

FIGS. 60A-60B are cross-sectional side views of a distal end of adelivery catheter for delivering the prosthetic heart valve device ofFIG. 59C to a native mitral valve in the heart in accordance withanother embodiment of the present technology.

FIG. 61 is a side view of a prosthetic heart valve device having firstand second anchoring members for engaging supra-annular and subannulartissue of the mitral valve, respectively, in accordance with yet anotherembodiment of the present technology.

FIGS. 62A-62C are partial cross-sectional side views of a distal end ofa delivery system showing delivery of the prosthetic heart valve deviceof FIG. 61 at a mitral valve in accordance with another embodiment ofthe present technology.

FIG. 63 is an isometric side view of a prosthetic heart valve devicehaving an anchoring member with a supra-annular engaging rim and asubannular engaging ring in accordance with a further embodiment of thepresent technology.

FIGS. 64A-64D are side views of the prosthetic heart valve device ofFIG. 63 showing embodiments of methods for deploying the device at themitral valve annulus in accordance with aspects of the presenttechnology.

FIG. 65A is a cross-sectional view of a prosthetic heart valve devicehaving an inflatable anchoring member and shown implanted in a nativemitral valve of a heart in accordance with another embodiment of thepresent disclosure.

FIG. 65B is a partial cross-sectional side view of a distal end of adelivery system suitable for delivery of the prosthetic heart valvedevice of FIG. 65A in accordance with another embodiment of the presenttechnology.

FIGS. 66A-66D are cross-sectional views of prosthetic heart valvedevices having fillable chambers in accordance with additionalembodiments of the present technology.

FIGS. 67A-67B are isometric views of additional embodiments ofprosthetic heart valve devices in accordance with aspects of the presenttechnology.

FIGS. 68A-68B are side views of prosthetic heart valve devices having apositioning element in accordance with an additional embodiments of thepresent technology.

FIGS. 69A-69E are cross-sectional and side views of prosthetic heartvalve devices shown in an expanded configuration and configured inaccordance with an additional embodiment of the present technology.

FIG. 70 is a cross-sectional side view of another prosthetic heart valvedevice configured in accordance with an embodiment of the presenttechnology.

FIG. 71 is a cross-sectional side view of yet another prosthetic heartvalve device configured in accordance with an embodiment of the presenttechnology.

DETAILED DESCRIPTION

Specific details of several embodiments of the technology are describedbelow with reference to FIGS. 1-71. Although many of the embodiments aredescribed below with respect to devices, systems, and methods forpercutaneous replacement of a native mitral valve using prosthetic valvedevices, other applications and other embodiments in addition to thosedescribed herein are within the scope of the technology. Additionally,several other embodiments of the technology can have differentconfigurations, components, or procedures than those described herein. Aperson of ordinary skill in the art, therefore, will accordinglyunderstand that the technology can have other embodiments withadditional elements, or the technology can have other embodimentswithout several of the features shown and described below with referenceto FIGS. 1-71.

With regard to the terms “distal” and “proximal” within thisdescription, unless otherwise specified, the terms can reference arelative position of the portions of a prosthetic valve device and/or anassociated delivery device with reference to an operator and/or alocation in the vasculature or heart. For example, in referring to adelivery catheter suitable to deliver and position various prostheticvalve devices described herein, “proximal” can refer to a positioncloser to the operator of the device or an incision into thevasculature, and “distal” can refer to a position that is more distantfrom the operator of the device or further from the incision along thevasculature (e.g., the end of the catheter). With respect to aprosthetic heart valve device, the terms “proximal” and “distal” canrefer to the location of portions of the device with respect to thedirection of blood flow. For example, proximal can refer to an upstreamposition or a position of blood inflow, and distal can refer to adownstream position or a position of blood outflow. For ease ofreference, throughout this disclosure identical reference numbers and/orletters are used to identify similar or analogous components orfeatures, but the use of the same reference number does not imply thatthe parts should be construed to be identical. Indeed, in many examplesdescribed herein, the identically numbered parts are distinct instructure and/or function. The headings provided herein are forconvenience only.

Overview

Systems, devices and methods are provided herein for percutaneousreplacement of native heart valves, such as mitral valves. Several ofthe details set forth below are provided to describe the followingexamples and methods in a manner sufficient to enable a person skilledin the relevant art to practice, make and use them. Several of thedetails and advantages described below, however, may not be necessary topractice certain examples and methods of the technology. Additionally,the technology may include other examples and methods that are withinthe scope of the claims but are not described in detail.

Embodiments of the present technology provide systems, methods andapparatus to treat valves of the body, such as heart valves includingthe mitral valve. The apparatus and methods enable a percutaneousapproach using a catheter delivered intravascularly through a vein orartery into the heart. Additionally, the apparatus and methods enableother less-invasive approaches including trans-apical, trans-atrial, anddirect aortic delivery of a prosthetic replacement valve to a targetlocation in the heart. The apparatus and methods enable a prostheticdevice to be anchored at a native valve location by engagement with asubannular surface of the valve annulus and/or valve leaflets.Additionally, the embodiments of the devices and methods as describedherein can be combined with many known surgeries and procedures, such asknown methods of accessing the valves of the heart (e.g., the mitralvalve or triscuspid valve) with antegrade or retrograde approaches, andcombinations thereof.

The devices and methods described herein provide a valve replacementdevice that has the flexibility to adapt and conform to thevariably-shaped native mitral valve anatomy while mechanically isolatingthe prosthetic valve from the anchoring portion of the device. Severalembodiments of the device effectively absorb the distorting forcesapplied by the native anatomy. The device has the structural strengthand integrity necessary to withstand the dynamic conditions of the heartover time, thus permanently anchoring a replacement valve and making itpossible for the patient to resume a substantially normal life. Thedevices and methods further deliver such a device in a less-invasivemanner, providing a patient with a new, permanent replacement valve butalso with a lower-risk procedure and a faster recovery.

In accordance with various embodiments of the present technology, adevice for repair or replacement of a native valve of a heart isdisclosed. The native valve has an annulus and leaflets, and the deviceincludes an anchoring member having a first portion configured to engagetissue on or under the annulus and to deform in a non-circular shape toconform to the tissue. The anchoring member also can include a secondportion. The device also includes a valve support coupled to the secondportion of the anchoring member and configured to support a prostheticvalve and having a cross-sectional shape. In various embodiments, thefirst portion of the anchoring member is mechanically isolated from thevalve support such that the cross-sectional shape of the valve supportremains sufficiently stable so that the prosthetic valve remainscompetent when the anchoring member is deformed in the non-circularshape.

Some embodiments of the disclosure are directed to prosthetic heartvalve devices for implantation at a native mitral valve wherein themitral valve has an annulus and leaflets. In one embodiment, the devicecan have an anchoring member positionable in a location between theleaflets, wherein a first portion of the anchoring member is expandableto a dimension larger than a corresponding dimension of the annulus. Inthis embodiment, upstream movement of the anchoring member is blocked byengagement of the upstream portion with tissue on or near the annulus.The anchoring member can also include a second portion. The device canalso include a valve support coupled to the second portion of theanchoring member, wherein an upstream region of the valve support isspaced radially inward from at least the first portion of the anchoringmember. The valve support can be configured to support a prostheticvalve.

In another arrangement, a device for implantation at a native valvehaving an annulus and leaflets can include a hyperboloidic anchoringmember having an upstream end configured to engage an inward facingsurface of the leaflets downstream of the annulus and a downstream end,wherein the upstream end has a larger cross-sectional area than thedownstream end. The device can also include a valve support positionedin the anchoring member and configured to support a prosthetic valve.The valve support is coupled to the anchoring member at a locationspaced substantially downstream from the upstream end and is uncoupledto the anchoring member at the upstream end.

Other aspects of the disclosure are directed to prosthetic heart valvedevices for repair or replacement of a native heart valve of a patient,wherein the heart valve has an annulus and leaflets. In one embodiment,the device includes an anchoring member having a first portion having afirst cross-sectional dimension and second portion having a secondcross-sectional dimension less than the first cross-sectional dimension.The first portion is configured to engage cardiac tissue to retain theanchoring member in a fixed longitudinal position relative to theannulus. The device can also include a valve support coupled to thesecond portion of the anchoring member and configured to support aprosthetic valve. The valve support can be radially separated from thefirst portion of the anchoring member such that the first portion candeform inwardly without substantially deforming the valve support.

In a further arrangement, the present disclosure also is directed to adevice for implantation at a native heart valve. The device can includean anchoring member having an upstream end configured to engage tissueon or downstream of a native annulus of the heart valve, and a valvesupport configured to support a prosthetic valve. The valve support canbe coupled to the anchoring member. In some arrangements, the anchoringmember can resist upstream migration of the device without an element ofthe device extending behind native valve leaflets.

In another embodiment, the device can include an anchoring memberpositionable between the leaflets of the native valve. The anchoringmember can have a plurality of tissue engaging elements on an upstreamend and/or on an exterior surface which are configured to engage cardiactissue on or near the annulus so as to prevent migration of the devicein the upstream direction. The device can also include a valve supportpositioned within an interior of the anchoring member and coupled to adownstream portion of the anchoring member, wherein the valve support isradially separated from at least an upstream portion of the anchoringmember.

Further embodiments of the disclosure are directed to a device forrepair or replacement of a native mitral valve having an annulus and apair of leaflets that include a support structure having an upperregion, a lower region, and an interior to retain a prosthetic valve.The device can also include an anchoring member surrounding at least aportion of the support structure, wherein the anchoring member ispositionable between the leaflets and has a plurality of flexibleelements (e.g., wires, laser cut metal elements, etc.) arranged in adiamond pattern, an upper portion, and a lower portion. The upperportion of the anchoring member can be flared outwardly in a proximaldirection such that proximal ends of the flexible elements pointradially outward so as to engage cardiac tissue on or near the annulusand inhibit migration of the device in the upstream direction. The lowerregion of the support structure can be coupled to the lower portion ofthe anchoring member, and the lower region of the support structure canbe mechanically isolated from at least deformation of the flared upperportion of the anchoring member.

Other embodiments of the disclosure are directed to prosthetic heartvalve devices having a cylindrical support and an anchor defined by astructure separate from the cylindrical support. The cylindrical supportcan have a longitudinal axis and an interior along the longitudinal axisthrough which blood may flow. The anchor can have a non-circularcross-section with an outwardly flared upstream end configured to engagesubannular tissue of a mitral valve. The anchor can also surround thecylindrical support and be coupled to the support at a downstream endopposite the upstream end.

In a further embodiment, the device can include an expandable valvesupport configured for placement between the two leaflets. The supportcan have a first region, a second region and an interior in which avalve may be coupled. The device can also include an anchoring memberhaving a first portion and a second portion, the second portion coupledto the second region of the valve support. The first portion of theanchoring member can extend outwardly away from the second portion. Theanchoring member can have a first perimeter at the first portionconfigured to engage tissue on or near the annulus. The anchoring membercan be mechanically isolated from the valve support such that a forceexerted radially at or near the first perimeter will not substantiallyalter a shape of the valve support.

Additional embodiments are directed to devices to treat a heart valve ofa patient that include an inner frame and an outer frame coupled to theinner frame. The inner frame can have an outer surface and an innersurface that is configured to support a prosthetic valve. The outerframe can have an upper portion with a cross-sectional dimension greaterthan a corresponding cross-sectional dimension of an annulus of themitral valve, wherein the upper portion is configured to engage tissueat or below the annulus of the mitral valve. The upper portion can alsoprevent migration of the device in an upward or upstream directionduring ventricular systole. Further, the upper portion of the outerframe can be mechanically isolated from the inner frame.

In a further embodiment, the device can include a cylindrical innerskeleton and an outer skeleton coupled to the inner skeleton andpositionable between the leaflets downstream of the annulus. The outerskeleton can be deformable to a non-circular cross-section while theinner skeleton remains substantially circular in cross-section. Theinner skeleton can have an interior to which a prosthetic valve may becoupled. The outer skeleton can have a plurality of flexible elements(e.g., wires, laser cut metal elements, etc.), wherein at least aportion of the flexible elements can be configured to engage nativesubannular tissue so as to prevent migration of the device in anupstream direction. In one embodiment, the plurality of flexible wiresare arranged in a diamond configuration.

In yet a further embodiment, a prosthetic mitral valve device caninclude a valve support having upstream and downstream ends, an interiorin which a valve may be coupled, and a perimeter. The device can alsoinclude an anchoring member having a flared upstream portion and adownstream portion coupled to the perimeter of the valve support. Theupstream portion can be mechanically isolated from the valve support andcan be configured to engage subannular tissue of a native mitral valve.Additionally, the device can be moveable into a plurality ofconfigurations including a first configuration in which the valvesupport and the anchoring member are radially contracted, and whereinthe valve support has a first cross-sectional shape. The device can alsomove into a second configuration in which the valve support and theanchoring member are radially expanded and in which the valve supporthas a second cross-sectional shape. Additionally, the device can moveinto a third configuration in which the anchoring member is engaged withand deformed by the subannular tissue while the valve support remains inthe second cross-sectional shape.

In some embodiments, the device may comprise an atrial retainerextending from the anchoring member or the valve support to a positionat least partially upstream of the native mitral annulus. The atrialextension member may comprise an atrial engagement structure adapted toengage an upstream surface (e.g., supra-annular surface) of the annulusand/or an interior wall of the atrium for further stabilizing oranchoring the device. For example, the atrial retainer can blockdownstream movement of the device.

Some embodiments of the device may further comprise one or morestabilizing members to inhibit the device from tilting or beingdisplaced laterally. The stabilizing members may comprise a plurality ofarms extending radially outwardly from the valve support and/or theanchoring member. The arms may be configured to extend behind the nativeleaflets and/or into engagement with the ventricular wall or papillarymuscles.

A further embodiment, in accordance with another aspect of the presentdisclosure, is directed to a device for implantation at a native mitralvalve, wherein the native mitral valve has an annulus and leaflets. Thedevice can include a valve support having upstream and downstream ends,an interior in which a valve may be coupled, and an outer surface, andinclude a first anchoring member having a first flared upstream portionand a first downstream portion coupled to the outer surface of the valvesupport. In other embodiments, the first downstream portion can becoupled to inner surface of the valve support, or in some embodiments,to an end of the valve support. The device can also include a secondanchoring member at least partially surrounding the first anchoringmember. The first upstream portion of the first anchoring member can bemechanically isolated from the valve support and configured to engagesupra-annular tissue of the native mitral valve. The second anchoringmember can have a second flared upstream portion and a second downstreamportion coupled to the outer surface of the valve support, wherein thesecond upstream portion can be mechanically isolated from the valvesupport and is configured to engage subannular tissue of the nativemitral valve.

In yet a further embodiment, the device for implantation can include aradially expandable anchoring member configured to engage native tissueon or downstream of the annulus. The anchoring member can have a firstlongitudinal length on a posterior leaflet-facing side and a secondlength on an anterior leaflet-facing side. In certain embodiments, thefirst length can be greater than the second length such that occlusionof a left ventricle outflow tract (LVOT) is limited. The device can alsoinclude a valve support, or alternatively a prosthetic valve, coupled toan interior or to an end of the anchoring member.

Other embodiments of the present technology provide a device forimplantation at a native mitral valve having an annulus and leaflets,wherein the device includes a valve support having upstream anddownstream ends, an interior in which a valve may be coupled, and anouter surface. The device can also include an anchoring member having aflared upstream portion and a downstream portion coupled to the outersurface of the valve support, wherein the upstream portion can have anupper ring and a lower ring coupled to the upper ring. The device canfurther include a plurality of flexible annulus engaging elementsdistributed around a circumference of the anchoring member and couplingthe upper ring to the lower ring. The lower ring is configured to movein an upstream direction toward the upper ring such that the annulus isreceived between the upper and lower rings and within the annulusengaging elements.

The disclosure further provides systems for delivery of prostheticvalves and other devices using endovascular or other minimally invasiveforms of access. For example, embodiments of the present technologyprovide a system to treat a mitral valve of a patient, in which themitral valve has an annulus. The system comprises a device to treat themitral valve as described herein and a catheter having a lumenconfigured to retain the device within the catheter.

In other aspects, a system for replacing a native valve in a patient isprovided. The system can include an elongated catheter body having adistal end and a proximal end, and a housing coupled to the distal endof the catheter body and having a closed end and an open end. The systemcan also include a plunger within the housing which is axially movablerelative to the housing, and an actuator at the proximal end of thecatheter body and coupled to the plunger such that moving the actuatormoves the housing axially relative to the plunger. The system canfurther include a prosthetic valve device having a collapsedconfiguration and an expanded configuration. The prosthetic valve devicecan be positionable in the housing in the collapsed configuration andcan be releasable proximally from the housing by moving the actuator.

In yet another aspect, embodiments of the present technology provide amethod of treating a heart valve of a patient. The mitral valve has anannulus and leaflets coupled to the annulus. The method can includeimplanting a device as described herein within or adjacent to theannulus. The device, in some embodiments, can include a valve supportcoupled to and at least partially surrounded by an anchoring member. Theanchoring member can be disposed between the leaflets and an upstreamportion of the anchoring member can be configured to engage tissue on ordownstream of the annulus to prevent migration of the device in anupstream direction. Further, the valve support can be mechanicallyisolated from the anchoring member at least at the upstream portion.

In yet a further aspect, embodiments of the present technology provide amethod for replacement of a native mitral valve having an annulus andleaflets. The method can include positioning a device as describedherein between the leaflets, while the device is in a collapsedconfiguration. The method can also include allowing the prostheticdevice to expand such that an anchoring member of the prosthetic deviceis in a subannular position in which it engages tissue on or downstreamof the annulus. The anchoring member can have a diameter larger than acorresponding diameter of the annulus in the subannular position. Themethod can further include allowing a valve support to expand within theanchoring member, wherein the valve support is coupled to the anchoringmember. In various embodiments, the valve support can be mechanicallyisolated from the anchoring member such that deformation of theanchoring member when the anchoring member engages the tissue does notsubstantially deform the valve support. In some arrangements, certainregions of the valve support may deform, but a support region suitablefor retaining a prosthetic valve does not substantially deform such thatleaflet coaptation of the prosthetic valve would not be compromised.

The devices and methods disclosed herein can be configured for treatingnon-circular, asymmetrically shaped valves and bileaflet or bicuspidvalves, such as the mitral valve. Many of the devices and methodsdisclosed herein can further provide for long-term (e.g., permanent) andreliable anchoring of the prosthetic device even in conditions where theheart or native valve may experience gradual enlargement or distortion.

Cardiac and Mitral Valve Physiology

FIGS. 1 and 2 show a normal heart H. The heart comprises a left atriumthat receives oxygenated blood from the lungs via the pulmonary veins PVand pumps this oxygenated blood through the mitral valve MV into theleft ventricle LV. The left ventricle LV of a normal heart H in systoleis illustrated in FIG. 2. The left ventricle LV is contracting and bloodflows outwardly through the aortic valve AV in the direction of thearrows. Back flow of blood or “regurgitation” through the mitral valveMV is prevented since the mitral valve is configured as a “check valve”which prevents back flow when pressure in the left ventricle is higherthan that in the left atrium LA.

The mitral valve MV comprises a pair of leaflets having free edges FEwhich meet evenly, or “coapt” to close, as illustrated in FIG. 2. Theopposite ends of the leaflets LF are attached to the surrounding heartstructure via an annular region of tissue referred to as the annulus AN.FIG. 3 is a schematic cross-sectional side view of an annulus andleaflets of a mitral valve. As illustrated, the opposite ends of theleaflets LF are attached to the surrounding heart structure via afibrous ring of dense connective tissue referred to as the annulus AN,which is distinct from both the leaflet tissue LF as well as theadjoining muscular tissue of the heart wall. The leaflets LF and annulusAN are comprised of different types of cardiac tissue having varyingstrength, toughness, fibrosity, and flexibility. Furthermore, the mitralvalve MV may also comprise a unique region of tissue interconnectingeach leaflet LF to the annulus AN, referred to herein as leaflet/annulusconnecting tissue LAC (indicated by overlapping cross-hatching). Ingeneral, annular tissue AN is tougher, more fibrous, and stronger thanleaflet tissue LF.

Referring to FIG. 2, the free edges FE of the mitral leaflets LF aresecured to the lower portions of the left ventricle LV through chordaetendineae CT (referred to hereinafter “chordae”) which include aplurality of branching tendons secured over the lower surfaces of eachof the valve leaflets LF. The chordae CT in turn, are attached to thepapillary muscles PM, which extend upwardly from the lower wall of theleft ventricle LV and interventricular septum IVS.

Referring now to FIGS. 4A to 4B, a number of structural defects in theheart can cause mitral valve regurgitation. Ruptured chordae RCT, asshown in FIG. 4A, can cause a valve leaflet LF2 to prolapse sinceinadequate tension is transmitted to the leaflet via the chordae. Whilethe other leaflet LF1 maintains a normal profile, the two valve leafletsdo not properly meet and leakage from the left ventricle LV into theleft atrium LA will occur, as shown by the arrow.

Regurgitation also occurs in the patients suffering from cardiomyopathywhere the heart is dilated and the increased size prevents the valveleaflets LF from meeting properly, as shown in FIG. 4B. The enlargementof the heart causes the mitral annulus to become enlarged, making itimpossible for the free edges FE to meet during systole. The free edgesof the anterior and posterior leaflets normally meet along a line ofcoaptation C as shown in FIG. 5A, but a significant gap G can be left inpatients suffering from cardiomyopathy, as shown in FIG. 5B.

Mitral valve regurgitation can also occur in patients who have sufferedischemic heart disease where the functioning of the papillary muscles PMis impaired, as illustrated in FIG. 4A. As the left ventricle LVcontracts during systole, the papillary muscles PM do not contractsufficiently to effect proper closure. One or both of the leaflets LF1and LF2 then prolapse. Leakage again occurs from the left ventricle LVto the left atrium LA.

FIGS. 5A-5C further illustrate the shape and relative sizes of theleaflets L of the mitral valve. Referring to FIG. 5C, it may be seenthat the overall valve has a generally “D”-shape or kidney-like shape,with a long axis MVA1 and a short axis MVA2. In healthy humans the longaxis MVA1 is typically within a range from about 33.3 mm to about 42.5mm in length (37.9+/−4.6 mm), and the short axis MVA2 is within a rangefrom about 26.9 to about 38.1 mm in length (32.5+/−5.6 mm). However,with patients having decreased cardiac function these values can belarger, for example MVA1 can be within a range from about 45 mm to 55 mmand MVA2 can be within a range from about 35 mm to about 40 mm. The lineof coaptation C is curved or C-shaped, thereby defining a relativelylarge anterior leaflet AL and substantially smaller posterior leaflet PL(FIG. 5A). Both leaflets appear generally crescent-shaped from thesuperior or atrial side, with the anterior leaflet AL beingsubstantially wider in the middle of the valve than the posteriorleaflet. As illustrated in FIG. 5A, at the opposing ends of the line ofcoaptation C the leaflets join together at corners called theanterolateral commissure AC and posteromedial commissure PC,respectively.

FIG. 5C shows the shape and dimensions of the annulus of the mitralvalve. The annulus is an annular area around the circumference of thevalve comprised of fibrous tissue which is thicker and tougher than thatof the leaflets LF and distinct from the muscular tissue of theventricular and atrial walls. The annulus may comprise a saddle-likeshape with a first peak portion PP1 and a second peak portion PP2located along an interpeak axis IPD, and a first valley portion VP1 anda second valley portion VP2 located along an intervalley axis IVD. Thefirst and second peak portion PP1 and PP2 are higher in elevationrelative to a plane containing the nadirs of the two valley portionsVP1, VP2, typically being about 8-19 mm higher in humans, thus givingthe valve an overall saddle-like shape. The distance between the firstand second peak portions PP1, PP2, referred to as interpeak span IPD, issubstantially shorter than the intervalley span IVD, the distancebetween first and second valley portions VP1, VP2.

A person of ordinary skill in the art will recognize that the dimensionsand physiology of the patient may vary among patients, and although somepatients may comprise differing physiology, the teachings as describedherein can be adapted for use by many patients having variousconditions, dimensions and shapes of the mitral valve. For example, workin relation to embodiments suggests that some patients may have a longdimension across the annulus and a short dimension across the annuluswithout well-defined peak and valley portions, and the methods anddevice as described herein can be configured accordingly.

Access to the Mitral Valve

Access to the mitral valve or other atrioventricular valve can beaccomplished through the patient's vasculature in a percutaneous manner.By percutaneous it is meant that a location of the vasculature remotefrom the heart is accessed through the skin, typically using a surgicalcut down procedure or a minimally invasive procedure, such as usingneedle access through, for example, the Seldinger technique. The abilityto percutaneously access the remote vasculature is well-known anddescribed in the patent and medical literature. Depending on the pointof vascular access, the approach to the mitral valve may be antegradeand may rely on entry into the left atrium by crossing the inter-atrialseptum. Alternatively, approach to the mitral valve can be retrogradewhere the left ventricle is entered through the aortic valve. Oncepercutaneous access is achieved, the interventional tools and supportingcatheter(s) may be advanced to the heart intravascularly and positionedadjacent the target cardiac valve in a variety of manners, as describedherein.

Using a trans-septal approach, access is obtained via the inferior venacava IVC or superior vena cava SVC, through the right atrium RA, acrossthe inter-atrial septum IAS and into the left atrium LA above the mitralvalve MV.

As shown in FIG. 6A, a catheter 1 having a needle 2 may be advanced fromthe inferior vena cava IVC into the right atrium RA. Once the catheter 1reaches the anterior side of the inter-atrial septum IAS, the needle 2may be advanced so that it penetrates through the septum, for example atthe fossa ovalis FO or the foramen ovate into the left atrium LA. Atthis point, a guidewire may be exchanged for the needle 2 and thecatheter 1 withdrawn.

As shown in FIG. 6B, access through the inter-atrial septum IAS mayusually be maintained by the placement of a guide catheter 4, typicallyover a guidewire 6 which has been placed as described above. The guidecatheter 4 affords subsequent access to permit introduction of thedevice to replace the mitral valve, as described in more detail herein.

In an alternative antegrade approach (not shown), surgical access may beobtained through an intercostal incision, preferably without removingribs, and a small puncture or incision may be made in the left atrialwall. A guide catheter may then be placed through this puncture orincision directly into the left atrium, sealed by a purse string-suture.

The antegrade or trans-septal approach to the mitral valve, as describedabove, can be advantageous in many respects. For example, the use of theantegrade approach will usually allow for more precise and effectivecentering and stabilization of the guide catheter and/or prostheticvalve device. Precise positioning facilitates accuracy in the placementof the prosthetic valve device. The antegrade approach may also reducethe risk of damaging the subvalvular device during catheter andinterventional tool introduction and manipulation. Additionally, theantegrade approach may decrease risks associated with crossing theaortic valve as in retrograde approaches. This can be particularlyrelevant to patients with prosthetic aortic valves, which cannot becrossed at all or without substantial risk of damage.

An example of a retrograde approach to the mitral valve is illustratedin FIGS. 7 and 8. The mitral valve MV may be accessed by an approachfrom the aortic arch AA, across the aortic valve AV, and into the leftventricle LV below the mitral valve MV. The aortic arch AA may beaccessed through a conventional femoral artery access route, as well asthrough more direct approaches via the brachial artery, axillary artery,radial artery, or carotid artery. Such access may be achieved with theuse of a guidewire 6. Once in place, a guide catheter 4 may be trackedover the guidewire 6. Alternatively, a surgical approach may be takenthrough an incision in the chest, preferably intercostally withoutremoving ribs, and placing a guide catheter through a puncture in theaorta itself. The guide catheter 4 affords subsequent access to permitplacement of the prosthetic valve device, as described in more detailherein.

In some specific instances, a retrograde arterial approach to the mitralvalve may be choosen due to certain advantages. For example, use of theretrograde approach can eliminate the need for a trans-septal puncture.The retrograde approach is also more commonly used by cardiologists andthus has the advantage of familiarity.

An additional approach to the mitral valve is via trans-apical puncture,as shown in FIG. 9. In this approach, access to the heart is gained viathoracic incision, which can be a conventional open thoracotomy orsternotomy, or a smaller intercostal or sub-xyphoid incision orpuncture. An access cannula is then placed through a puncture, sealed bya purse-string suture, in the wall of the left ventricle at or near theapex of the heart. The catheters and prosthetic devices of the inventionmay then be introduced into the left ventricle through this accesscannula.

The trans-apical approach has the feature of providing a shorter,straighter, and more direct path to the mitral or aortic valve. Further,because it does not involve intravascular access, the trans-apicalprocedure can be performed by surgeons who may not have the necessarytraining in interventional cardiology to perform the catheterizationsrequired in other percutaneous approaches.

The prosthetic treatment device may be specifically designed for theapproach or interchangeable among approaches. A person of ordinary skillin the art can identify an appropriate approach for an individualpatient and design the treatment apparatus for the identified approachin accordance with embodiments described herein.

Orientation and steering of the prosthetic valve device can be combinedwith many known catheters, tools and devices. Such orientation may beaccomplished by gross steering of the device to the desired location andthen refined steering of the device components to achieve a desiredresult.

Gross steering may be accomplished by a number of methods. A steerableguidewire may be used to introduce a guide catheter and the prosthetictreatment device into the proper position. The guide catheter may beintroduced, for example, using a surgical cut down or Seldinger accessto the femoral artery in the patient's groin. After placing a guidewire,the guide catheter may be introduced over the guidewire to the desiredposition. Alternatively, a shorter and differently shaped guide cathetercould be introduced through the other routes described above.

A guide catheter may be pre-shaped to provide a desired orientationrelative to the mitral valve. For access via the trans-septal approach,the guide catheter may have a curved, angled or other suitable shape atits tip to orient the distal end toward the mitral valve from thelocation of the septal puncture through which the guide catheterextends. For the retrograde approach, as shown in FIGS. 7 and 8, guidecatheter 4 may have a pre-shaped J-tip which is configured so that itturns toward the mitral valve MV after it is placed over the aortic archAA and through the aortic valve AV. As shown in FIG. 7, the guidecatheter 4 may be configured to extend down into the left ventricle LVand to assume a J-shaped configuration so that the orientation of aninterventional tool or catheter is more closely aligned with the axis ofthe mitral valve MV. In either case, a pre-shaped guide catheter may beconfigured to be straightened for endovascular delivery by means of astylet or stiff guidewire which is passed through a lumen of the guidecatheter. The guide catheter might also have pull-wires or other meansto adjust its shape for more fine steering adjustment.

Selected Embodiments of Prosthetic Heart Valve Devices and Methods

Embodiments of the present technology as described herein can be used totreat one or more of the valves of the heart as described herein, and inparticular embodiments, can be used for treatment of the mitral valve.Introductory examples of prosthetic heart valve devices, systemcomponents and associated methods in accordance with embodiments of thepresent technology are described in this section with reference to FIGS.10A-56. It will be appreciated that specific elements, substructures,advantages, uses, and/or other features of the embodiments describedwith reference to FIGS. 10A-56 can be suitably interchanged, substitutedor otherwise configured with one another and/or with the embodimentsdescribed with reference to FIGS. 57A-71 in accordance with additionalembodiments of the present technology. Furthermore, suitable elements ofthe embodiments described with reference to FIGS. 10A-71 can be used asstand-alone and/or self-contained devices.

Systems, devices and methods are provided herein for percutaneousimplantation of prosthetic heart valves in a heart of a patient. In someembodiments, methods and devices are presented for the treatment ofvalve disease by minimally invasive implantation of artificialreplacement heart valves. In one embodiment, the artificial replacementvalve can be a prosthetic valve device suitable for implantation andreplacement of a mitral valve between the left atrium and left ventriclein the heart of a patient. In another embodiment, the prosthetic valvedevice can be suitable for implantation and replacement of another valve(e.g., a bicuspid or tricuspid valve) in the heart of the patient. FIG.10A shows an isometric view of a prosthetic heart valve device 100 in anexpanded configuration 102 in accordance with an embodiment of thepresent technology, and FIG. 10B is a schematic illustration of across-sectional view of a heart depicting the left atrium, leftventricle, and native mitral valve of the heart. FIG. 10B also shows anembodiment of the expandable prosthetic valve device 100 implanted inthe native mitral valve region of the heart.

As shown in FIG. 10A, the device 100 can include a flexible anchoringmember 110 at least partially surrounding and coupled to an inner valvesupport 120. The device 100 can further include a prosthetic valve 130coupled to, mounted within, or otherwise carried by the valve support120. FIGS. 10C-10F are side, perspective cut-away, top, and bottomviews, respectively, of the prosthetic heart valve device 100 inaccordance with the present technology. The device 100 can also includeone or more sealing members 140 and tissue engaging elements 170. Forexample, the sealing member 140 can, in one embodiment, extend around aninner wall 141 of the anchoring member 110 and/or around an exteriorsurface 127 of the valve support 120 to prevent paravalvular (e.g.,paraprosthetic) leaks between the device 100 and the native tissueand/or between the anchoring member 110 and the valve support 120. Inanother specific embodiment, and as shown in FIG. 10A, the tissueengaging elements 170 can be spikes disposed on an upstream perimeter113 of the anchoring member 110 and extend in an upward and/or radiallyoutward direction to engage, and in some embodiments, penetrate thenative tissue to facilitate retention or maintain position of the devicein a desired implanted location. The tissue engaging elements 170 mayalso be included around an outer wall 142 of the anchoring member 110and can extend outwardly to engage and, in some embodiments, penetratethe native valve leaflets or other adjacent tissue. Additionally, thevalve support 120 can have a plurality of coupling features 180, such aseyelets, around an upstream end 121 to facilitate loading, retention anddeployment of the device 100 within and from a delivery catheter (notshown), as further described herein.

The prosthetic heart valve device 100 can be movable between a deliveryconfiguration (not shown), an expanded configuration 102 (FIG. 10A), anda deployed configuration 104 (FIG. 10B). In the delivery configuration,the prosthetic heart valve device 100 has a low profile suitable fordelivery through small-diameter guide catheters positioned in the heartvia the trans-septal, retrograde, or trans-apical approaches describedherein. In some embodiments, the delivery configuration of theprosthetic heart valve device 100 will preferably have an outer diameterno larger than about 8-10 mm for trans-septal approaches, about 8-10 mmfor retrograde approaches, or about 8-12 mm for trans-apical approachesto the mitral valve MV. As used herein, “expanded configuration” refersto the configuration of the device when allowed to freely expand to anunrestrained size without the presence of constraining or distortingforces. “Deployed configuration,” as used herein, refers to the deviceonce expanded at the native valve site and subject to the constrainingand distorting forces exerted by the native anatomy.

Referring back to FIG. 3, “subannular,” as used herein, refers to aportion of the mitral valve MV that lies on or downstream DN of theplane PO of the native orifice. As used herein, the plane PO of thenative valve orifice is a plane generally perpendicular to the directionof blood flow through the valve and which contains either or both themajor axis MVA1 or the minor axis MVA2 (FIG. 5C). Thus, a subannularsurface of the mitral valve MV is a tissue surface lying on theventricular side of the plane PO, and preferably one that facesgenerally downstream, toward the left ventricle LV. The subannularsurface may be disposed on the annulus AN itself or the ventricular wallbehind the native leaflets LF, or it may comprise a surface of thenative leaflets LF, either inward-facing IF or outward-facing OF, whichlies below the plane PO. The subannular surface or subannular tissue maythus comprise the annulus AN itself, the native leaflets LF,leaflet/annulus connective tissue, the ventricular wall or combinationsthereof.

In operation, the prosthetic heart valve device 100 can beintravascularly delivered to a desired location in the heart, such as anintracardiac location near the mitral valve MV, while in the delivery(e.g., collapsed) configuration within a delivery catheter (not shown).Referring to FIG. 10B, the device 100 can be advanced to a positionwithin or downstream of the native annulus AN where the device 100 canbe released from the delivery catheter to enlarge toward the expandedconfiguration 102 (FIG. 1 OA). The device 100 will engage the nativetissue at the desired location, which will deform or otherwise alter theshape of the device 100 into the deployed configuration 104 (FIG. 10B).Once released from the catheter, the device 100 can be positioned suchthat at least a portion of the flexible anchoring member 110 engages asubannular surface of the native valve so as to resist systolic forcesand prevent upstream migration of the device 100 (FIG. 10B). In theembodiment illustrated in FIG. 10B, the upstream perimeter 113 of theanchoring member 110 engages the inward-facing surfaces IF (FIG. 3) ofthe native leaflets LF, which are pushed outwardly and folded under thenative annulus AN. The leaflets LF engage a ventricular side of theannulus AN and are prevented from being pushed further in the upstreamdirection, thus maintaining the anchoring member 110 below the plane ofthe native valve annulus. The tissue engaging elements 170 can penetratethe tissue of the leaflets LF and/or the annulus AN to stabilize andfirmly anchor the device 100. In some embodiments, however, someportions of the anchoring member 110 may extend above the annulus AN,with at least some portions of the anchoring member 110 engaging tissuein a subannular location to prevent migration of the device 100 towardthe left atrium LA. As shown in FIG. 10B, the leaflets LF can lie inapposition against the outer wall 142 of the anchoring member 110forming a blood-tight seal with the sealing member 140. The tissueengaging elements 170 can apply pressure against or, in anotherembodiment, penetrate the annulus AN or leaflets LF along the outer wall142 of the anchoring member 110 to further stabilize the device 100 andprevent migration.

In accordance with aspects of the present technology, the proximal orupper end of the anchoring member 110, while in a deployed configuration104, conforms to the irregularly-shaped mitral annulus AN, effectivelysealing the device 100 against the native annulus AN to anchor thedevice and to prevent paravalvular leaks. As described further herein,the anchoring member 110 mechanically isolates the valve support 120from distorting forces present in the heart such that the anchoringmember 110 may adapt and/or conform to native forces while the valvesupport 120 maintains its structural integrity. Accordingly, theanchoring member 110 can be sufficiently flexible and resilient and/orcoupled to the valve support 120 in such a manner as to mechanicallyisolate the valve support 120 from the forces exerted upon the anchoringmember 110 by the native anatomy. Alternatively, or in addition to theabove features, the valve support 120 may be more rigid and/or havegreater radial strength than the radial strength of the anchoring member110 so as to maintain its cylindrical or other desired shape and toensure proper opening and closing of the prosthetic valve 130 housedwithin the valve support structure 120. In some embodiments, the valvesupport 120 has a radial strength of at least 100%, or in otherembodiments at least 200%, and in further embodiments at least 300%,greater than a radial strength of the anchoring member 110. In oneembodiment, the valve support 120 can have a radial strength ofapproximately 10 N to about 12 N. Thus, if deformed from its unbiasedshape by exerting a radially compressive force against itscircumference, the valve support 120 can exhibit a hoop force which isabout 2 to about 20 times greater for a given degree of deformation thanwill be exhibited by the anchoring member 110.

As illustrated in FIGS. 10A-10F, the anchoring member 110 has adownstream portion 111 and an upstream portion 112 opposite thedownstream portion 111 relative to a longitudinal axis 101 of the device100. The upstream portion 112 of the anchoring member 110 can be agenerally outward oriented portion of the device 100, as shown in FIG.10D. In one embodiment the anchoring member 110 has a generallyhyperboloidic shape, such as the shape of a two-sheet hyperboloid. Inanother example, the downstream portion 111 can be substantiallycircular in cross-section while the upstream portion 112 can begenerally non-circular. In some embodiments, the anchoring member 110can include a series of circumferentially positioned, resilientlydeformable and flexible longitudinal ribs 114 which, in someembodiments, are connected circumferentially by deformable and/orflexible connectors 116. Once deployed, at least a portion of theupstream ends of the longitudinal ribs 114 engage a subannular surfaceof the native valve (e.g., mitral valve). As described in more detailbelow, certain embodiments of longitudinal ribs 114 are configured topenetrate subannular tissue to anchor and further stabilize the device100.

Additionally, FIGS. 10A-10F also illustrate that the longitudinal ribs114 and/or circumferential connectors 116 may be arranged in a varietyof geometrical patterns. In the examples shown in FIGS. 10A-10F, theconnectors 116 are formed in a chevron configuration. One of ordinaryskill will recognize that diamond-shaped patterns, sinusoidalconfigurations, closed cells, open cells, or other circumferentiallyexpandable configurations are also possible. In some embodiments, thelongitudinal ribs 114 may be divided along their length into multiple,separated segments (not shown), e.g. where the connectors 116interconnect with the longitudinal ribs 114. The plurality of connectors116 and ribs 114 can be formed from a deformable material or from aresilient or shape memory material (e.g., nitinol). In otherembodiments, the anchoring member 110 can comprise a mesh or wovenconstruction in addition to or in place of the longitudinal ribs 114and/or circumferential connectors 116. For example, the anchoring member110 could include a tube or braided mesh formed from a plurality offlexible wires or filaments arranged in a diamond pattern or otherconfiguration. In another example, a metal tube can be laser cut toprovide a desired rib or strut geometry. The diamond configuration can,in some embodiments, provide column strength sufficient to inhibitmovement of the device 100 relative the annulus under the force ofsystolic blood pressure against the valve 130 mounted in the valvesupport 120. In a particular example, the anchoring member 120 can beformed of a preshaped nitinol tube having, for example, a wall thicknessof approximately 0.010 inches to about 0.030 inches.

FIGS. 11A-11E show several embodiments of valve supports 120 that can beused in embodiments of the prosthetic heart valve device 100 shown inFIGS. 10A-10F. FIGS. 11A-11D are side and isometric views of the valvesupport 120 shown in an expanded configuration 102, and FIG. 11E is anisometric view of another embodiment of a prosthetic heart valve device100 disposed in an expanded configuration 102 in accordance with thepresent technology. Referring to FIGS. 10A-10F and 11A-11E together,several embodiments of the valve support 120 can be generallycylindrical having an upstream end 121 and a downstream end 123 formedaround a longitudinal axis 101 with a circular, oval, elliptical,kidney-shaped, D-shaped, or other suitable cross-sectional shapeconfigured to support a tricuspid or other prosthetic valve 130. In someembodiments, the valve support 120 includes a plurality of posts 122connected circumferentially by a plurality of struts 124. The posts 122and struts 124 can be arranged in a variety of geometrical patterns thatcan expand and provide sufficient resilience and column strength formaintaining the integrity of the prosthetic valve 130. For example, theplurality of posts 122 can extend longitudinally across multiple rows ofstruts 124 to provide column strength to the valve support 120. However,in other embodiments, the valve support 120 can include a metallic,polymeric, or fabric mesh or a woven construction.

Generally, the plurality of posts 122 can extend along an axialdirection generally parallel to the longitudinal axis 101 and the struts124 can extend circumferentially around and transverse to thelongitudinal axis 101. The posts 122 can extend an entire longitudinalheight H₁ of the valve support 120 (FIG. 11A), or in another embodiment,the posts 122 can include a plurality of independent and separate postsegments (not shown) along the valve support height H₁. In oneembodiment the height H₁ can be approximately 14 mm to about 17 mm. Thestruts 124 can form a series of rings around the longitudinal axis 101,wherein each ring has a circumferentially expandable geometry. In theexample shown in FIGS. 11A, 11D and 11E, the struts 124 are formed in aseries of zig-zags and arranged in pairs 180 degrees out of phase witheach other so as to form a series of diamonds. Alternative expandablegeometries can include sinusoidal patterns, chevron configurations (FIG.11B), closed cells (FIG. 11C), open cells, or other expandableconfigurations. The plurality of struts 124 can attach to the pluralityof posts 122 so as to define a plurality of nodes 125 where the strutsand posts intersect. The plurality of struts 124 and the plurality ofposts 122 can be formed from a deformable material or a resilient orshape memory material (e.g., nitinol).

The anchoring member 110 and the valve support 120 may be made of thesame or, in some embodiments, different materials. In some embodiments,both the anchoring member 110 and the valve support 120 include aresilient biocompatible metal, such as stainless steel, nickel cobalt orcobalt chromium alloys such as MP35N, or nickel titanium alloys such asnitinol. Superelastic shape memory materials such as nitinol can allowthe device to be collapsed into a very low profile deliveryconfiguration suitable for delivery through the vasculature viacatheter, and allow self-expansion to a deployed configuration suitablysized to replace the target valve. In some embodiments, the anchoringmember 110 and/or the valve support 120 can be laser cut from a singlemetal tube into the desired geometry, creating a tubular scaffold ofinterconnected struts. Anchoring member 110 may then be shaped into adesired configuration, e.g. a flared, funnel-like or hyperboloid shape,using known shape-setting techniques for such materials.

As shown in FIGS. 11B-11E, the valve support 120 has an interior surface126 and an exterior surface 127, and the valve support 120 is configuredto receive or support the prosthetic valve 130 within an interior lumenof the valve support 120 to inhibit retrograde blood flow (e.g., bloodflow from the left ventricle into the left atrium). Accordingly, thevalve support 120 can provide a scaffold to which prosthetic valvetissue can be secured and provide a scaffold that has sufficient axialrigidity to maintain a longitudinal position of the prosthetic valve 130relative to the anchoring member 110. The valve support 120 can furtherprovide such a scaffold having radial rigidity to maintain circularity(or other desired cross-sectional shape) to ensure that leaflets 132 ofthe prosthetic valve 130 coapt or otherwise seal when the device 100 issubject to external radial pressure. In one embodiment, the valvesupport 120 can have a support region 145 along the longitudinal axis101 that is configured to attach to the prosthetic valve, or in otherembodiments, be aligned with the coaptation portion of the leaflets 132(shown in FIG. 11B).

The valve 130 may comprise a temporary or permanent valve adapted toblock blood flow in the upstream direction and allow blood flow in thedownstream direction through the valve support 120. The valve 130 mayalso be a replacement valve configured to be disposed in the valvesupport 120 after the device 100 is implanted at the native mitralvalve. The valve 130 can have a plurality of leaflets 132, and may beformed of various flexible and impermeable materials including PTFE,Dacron®, pyrolytic carbon, or other biocompatible materials or biologictissue such as pericardial tissue or xenograft valve tissue such asporcine heart tissue or bovine pericardium. Other aspects of valve 130are described further below. The interior surface 126 within the lumenof the valve support 120 can be covered at least partially by animpermeable sealing member 140 to prevent blood flow from inside thevalve support 120 to the outside of the valve support 120, where itcould leak around the exterior of the valve support 120. In anotherembodiment, the sealing member 140 may be affixed to the exteriorsurface 127 of the valve support 120 and, in either embodiment, may beintegrally formed with or attached directly to valve 130. In anadditional embodiment, the sealing member 140 can be applied on at leastportions of both the interior surface 126 and the exterior surface 127of the valve support 120.

As shown in FIGS. 11B-11E, the prosthetic valve 130 can be sutured,riveted, glued, bonded, mechanically interlocked, or otherwise fastenedto posts 122 or commissural attachment structures 128, which areconfigured to align with valve commissures C. The posts 122 orcommissural attachment structures 128 can include eyelets 129, loops, orother features formed thereon to facilitate attachment of sutures orother fastening means to facilitate attachment of the prosthetic valve130. In one embodiment, shown in FIG. 11B, the attachment structures 128can be integrated into the structural frame of the valve support 120such that the attachment structures 128 are distributed around thecircumference of the valve support 120 and function as posts 122. Inanother embodiment, shown in FIG. 11D, the attachment structures 128 canbe attachment pads formed on parts of the posts 122 (e.g., along anupper end of the posts 122). In a further embodiment, shown in FIG. 11E,the attachment structures 128 can be separate structures that can becoupled to posts 122, struts 124 or other components along the interiorsurface 126 of the valve support 120.

As illustrated in FIG. 11C, the prosthetic valve 130 may also beattached to the sealing member 140 or sleeve which is attached to theinterior surface 126 of the valve support 120, as described above. Onceattached, the prosthetic valve 130 can be suitable to collapse orcompress with the device 100 for loading into a delivery catheter (notshown). In one embodiment, the prosthetic valve 130 has a tri-leafletconfiguration, although various alternative valve configurations may beused, such as a bi-leaflet configuration. The design of the prostheticvalve 130, such as the selection of tri-leaflet vs. bi-leafletconfigurations, can be used to determine the suitable shape of the valvesupport 120. For example, for a tri-leaflet valve, the valve support 120can have a circular cross-section, while for a bi-leaflet valve,alternative cross-sectional shapes are possible such as oval or D-shapedcross-sections. In particular examples, the valve support can have acircular cross-sectional diameter of approximately 25 mm to about 32 mm,such as 27 mm.

In some arrangements, the valve support 120 can have a permanentprosthetic valve pre-mounted therein, or the valve support 120 may beconfigured to receive a separate catheter-delivered valve followingimplantation of the device 100 at the native mitral valve. Inarrangements where a permanent or replacement valve is desirable, thevalve support 120 can further include a temporary valve pre-mountedwithin the interior lumen. If a period of time between placement of thedevice 100 and further implantation of the permanent prosthetic valve isdesirable, a temporary valve sewn into or otherwise secured within thevalve support 120 can assure regulation of blood flow in the interim.For example, temporary valves may be used for a period of about 15minutes to several hours or up to a several days. Permanent orreplacement prosthetic valves may be implanted within a temporary valveor may be implanted after the temporary valve has been removed. Examplesof pre-assembled, percutaneous prosthetic valves include, e.g., theCoreValve ReValving® System from Medtronic/Corevalve Inc. (Irvine,Calif., USA), or the Edwards-Sapien® valve from Edwards Lifesciences(Irvine, Calif., USA). If adapted to receive a separatecatheter-delivered valve, the valve support 120 may have features withinits interior lumen or on its upper or lower ends to engage and retainthe catheter-delivered valve therein, such as inwardly extending ridges,bumps, prongs, or flaps. Additional details and embodiments regardingthe structure, delivery and attachment of prosthetic valves, temporaryvalves and replacement valves suitable for use with the prosthetic heartvalve devices disclosed herein can be found in International PCT PatentApplication No. PCT/US2012/043636, entitled “PROSTHETIC HEART VALVEDEVICES AND ASSOCIATED SYSTEMS AND METHODS,” filed Jun. 21, 2012, theentire contents of which are incorporated herein by reference.

In some arrangements, the anchoring member 110 is defined by a structureseparate from the valve support 120. For example, the anchoring member110 can be a first or outer frame or skeleton and the valve support 120can be a second or inner frame or skeleton. As such, the anchoringmember 110 can at least partially surround the valve support 120. Insome embodiments, the downstream portion 111 of the anchoring member 110can be coupled to the valve support 120 while the upstream portion 112is not connected or coupled to the valve support 120 in a manner thatunduly influences the shape of the valve support 120. For example, insome embodiments, the upstream portion 112 of the anchoring member 110can be configured to engage and deform to the shape of the native tissueon or under the annulus while the cross-sectional shape of the valvesupport 120 remains sufficiently stable. For example, the valve support120 (e.g., at least at the upstream end 121) can be spaced radiallyinward from the upstream portion 112 of the anchoring member 110 suchthat if the anchoring member 110 is deformed inwardly, at least theupstream end 121 of the valve support 120 remains substantiallyundeformed. As used herein, “substantially undeformed” can refer tosituations in which the valve support 120 is not engaged or deformed, orcan refer to scenarios in which the valve support 120 can deformslightly but the prosthetic valve 130 remains intact and competent(e.g., the leaflets 132 coapt sufficiently to prevent retrograde bloodflow). In such arrangements, leaflets 132 of the prosthetic valve 130can close sufficiently even when the device 100 is under systolicpressures or forces from the pumping action of the heart.

The longitudinal ribs 114 and/or circumferential connectors 116 can beless rigid than the posts 122 and/or struts 124 of the valve support120, allowing greater flexibility in the anchoring member 110 and/ormore stability to the shape and position of the valve support 120. Insome embodiments, the flexibility of the anchoring member 110 can allowthe anchoring member 110 to absorb distorting forces as well as allowthe device 100 to conform to the irregular, non-circular shape of thenative annulus (while leaving the valve support 120 substantiallyunaffected), encouraging tissue ingrowth and creating a seal to preventleaks between the device 100 and the native tissue. In addition, thelongitudinal ribs 114 and/or connectors 116 can be configured to pressradially outward against the native valve, ventricular and/or aorticstructures so as to anchor the device 100 in a desired position, as wellas maintain an upstream deployed circumference 150′ larger than that ofthe native annulus such that subannular positioning effectively preventsupstream migration of the device 100 (described further below in FIG.14C). Furthermore, the longitudinal ribs 114 can have sufficientresilience and column strength (e.g., axial stiffness) to preventlongitudinal collapse or eversion of the anchoring member 110 and/or thedevice 100 and to resist movement of the device in an upstreamdirection.

By structurally separating the anchoring member 110 from the valvesupport 120, the valve 130 and valve support 120 are effectivelymechanically isolated from the distorting forces exerted on theanchoring member 110 by the native tissue, e.g., radially compressiveforces exerted by the native annulus and/or leaflets, longitudinaldiastolic and systolic forces, hoop stress, etc. For example,deformation of the anchoring member 110 by the native tissue can changea cross-section of the anchoring member 110 (e.g., to a non-circular ornon-symmetrical cross-section), while the valve support 120 may besubstantially undeformed. In one embodiment, at least a portion of thevalve support 120 can be deformed by the radially compressive forces,for example, where the anchoring member 110 is coupled to the valvesupport 120 (e.g., the downstream end 123). However, the upstream end121 of the valve support 120 and/or the valve support region 145 (FIG.11B) is mechanically isolated from the anchoring member 110 and thecompressive forces such that at least the valve support region 145 canbe substantially undeformed. Thus the valve support 120, and at leastthe valve support region 145, can maintain a circular or other desirablecross-section so that the valve remains stable and/or competent. Theflexibility of the longitudinal ribs 114 can contribute to theabsorption of the distorting forces, and also aid in mechanicallyisolating the valve support 120 and valve 130 from the anchoring member110.

At an upstream end of the device 100 oriented toward the left atrium,the valve support 120 can be configured to sit below, even with, orabove the uppermost terminal of the upstream portion 112 of theanchoring member 110. At a downstream end of the device 100 orientedtoward and residing within the left ventricle, the anchoring member 110can be coupled to the valve support 120. Alternatively, the anchoringmember 110 can be coupled to the valve support 120 anywhere along alength of the valve support 120. The valve support 120 and anchoringmember 110 may be coupled by a variety of methods known in the art,e.g., suturing, soldering, welding, staples, rivets or other fasteners,mechanical interlocking, friction, interference fit, or any combinationthereof. In other embodiments, the valve support 120 and the anchoringmember 110 can be integrally formed with one another. In yet anotherembodiment, a sleeve or other overlaying structure (not shown) may beattached to both the anchoring member 110 and the valve support 120 tointerconnect the two structures.

FIGS. 12A-12C are side views of various longitudinal ribs 114 flexing inresponse to a distorting force F in accordance with further embodimentsof the present technology. The degree of flexibility of individuallongitudinal ribs 114 (and thus the anchoring member 110) may beconsistent among all ribs of an anchoring member 110, or, alternatively,some ribs 114 may be more flexible than other ribs 114 within the sameanchoring member 110. Likewise, a degree of flexibility of individualribs 114 may be consistent throughout an entire length of the rib 114 orthe degree of flexibility can vary along the length of each rib 114.

As shown FIGS. 12A-12C, the longitudinal ribs 114 (shown individually as114A-114C) may flex along their respective lengths in response todistorting forces F that can be applied by the surrounding tissue duringor after implantation of the device 100. In FIG. 12A, the rib 114A mayflex downward to a position 75′ or upward to a position 75″ in responseto an upward or downward force F₁, respectively. Similarly, in FIG. 12B,a rib 114B with multiple distinct segments 85A, 85B, 85C may flex and/orrotate inwardly/outwardly or side-to-side in response to alaterally-directed force F₂. The distinct segment 85A at the end of therib 114B may flex and/or rotate inwardly/outwardly or side-to-side(e.g., to position 85A′) in response to the laterally directed force F₂separate from lower distinct segments 85B and 85C. In otherarrangements, the segment 85A may flex and/or rotate (e.g., to position85AB′) with the distinct segment 85B or with both segments 85B and 85Ctogether (not shown). As shown in FIG. 12C, the rib 114C having agenerally linear shape when in a relaxed state, may also flex and/orrotate inwardly/outwardly or side-to-side (e.g., to positions 95′ or95″) in response to a laterally-directed force F₃, by bending to createa curved shape, or in another embodiment not shown, by bending so as tocreate two substantially linear segments.

Individual ribs 114 can also have a variety of shapes and be placed in avariety of positions around a circumference of the anchoring member 110.In some embodiments, the device 100 can include a first and secondplurality of ribs wherein the first plurality of ribs have acharacteristic different than the second plurality of ribs. Variouscharacteristics could include size of the rib, rib shape, rib stiffness,extension angle and the number of ribs within a given area of theanchoring member. In other embodiments, the longitudinal ribs can beunevenly or evenly spaced around an outer perimeter of the anchoringmember,

The ribs 114 can be positioned around a circumference oriented along thelongitudinal axis 101 of the anchoring member 110 to create any numberof overall cross-sectional geometries for the anchoring member 110,e.g., circular, D-shaped, oval, kidney, irregular, etc. FIG. 13A is aschematic, cross-sectional view of a prosthetic heart valve device inaccordance with another embodiment of the present technology, and FIGS.13B-13F are partial side views of prosthetic heart valve devicesillustrating a variety of longitudinal rib configurations in accordancewith additional embodiments of the present technology. Referring to FIG.13A, an individual rib 114 can comprise a plurality of linear segments,such as segments 85A and 85B. In the illustrated example, the ribsegment 85B is angled radially outwardly (e.g., angled away from thelongitudinal axis 101) by a first angle A₁. The rib segment 85B extendsin an upstream direction from its point of attachment to the valvesupport 120 at the downstream end of the segment 85B, thereby giving theanchoring member 110 a conical or flared shape, with a larger diameterD₂ at the upstream portion 112 and a smaller diameter D₃ at thedownstream portion 112 of the anchoring member 110. In one embodiment,the upper rib segment 85A can be angled at a steeper second angle A₂relative to the longitudinal axis 101 than lower rib segment 85B,resulting in a wider flared upstream portion 112A at the upstreamportion 112 of the anchoring member 110. In some arrangements, the widerflared upstream portion 112A may enhance sealing between the anchoringmember 110 and the native tissue, while the downstream portion 111 canprovide a more rigid geometry for resisting upstream movement of thedevice 100 when systolic forces are exerted on the device 100.Alternatively, the rib 114 can be arcuate over all or a portion of itslength, as shown in the partial side view of FIG. 13B.

In yet other embodiments, as illustrated by FIGS. 13C-13F, the rib 114can have a more complex shape defined by multiple distinct segments 85A,85B, 85C, etc. For example, as shown in FIG. 13C, the rib 114 includes alinear rib segment 85C generally parallel to the longitudinal axis 101connected at its upstream end to a linear and radially outwardlyextending rib segment 85B, where rib segment 85B is connected at itsupstream end to a more vertical rib segment 85A which is about parallelwith the longitudinal axis 101. Referring to FIG. 13D, the rib 114 caninclude a linear rib segment 85B generally parallel to longitudinal axis101 and connected at its upstream end to a linear and radially outwardlyextending rib segment 85A, which is generally perpendicular tolongitudinal axis 101. Referring to FIG. 13E, the rib 114 can include alinear rib segment 85C generally parallel to the longitudinal axis 101and connected at its upstream end to a linear and radially outwardlyextending rib segment 85B which is generally perpendicular to thelongitudinal axis 101. The rib segment 85B can further be connected atits most radially outward end to a vertical rib segment 85C generallyparallel with the longitudinal axis 101. In reference to FIG. 13F, therib 114 includes a linear segment 85D generally parallel with thelongitudinal axis 101 and connected at its upstream end to a radiallyoutwardly extending segment 85C which is generally perpendicular to thelongitudinal axis 101. The rib segment 85C can further be connected atits most radially outward end to a linear, vertical segment 85Bgenerally parallel with the longitudinal axis 101, and where 85B isconnected at its most radially outward end to a linear and radiallyinward extending segment 85A.

In the embodiments illustrated in FIGS. 13C-13F, the ribs 114 can becoupled to the valve support 120 (e.g., coupled to posts 122) in amanner to enhance mechanical isolation of the valve support 120. Forexample, the ribs 114 may be attached to the valve support 120 near thedownstream end of the ribs 114 such that a substantial portion of eachrib 114 upstream of the attachment point is movable and deformablerelative to the valve support 120, thereby allowing the rib 120 to flexradially outward or circumferentially back and forth relative to thevalve support 120. Additionally, one of ordinary skill in the art willrecognize that in any of the embodiments illustrated in FIGS. 13A-13F,any or all of the rib segments may have a curvature, and anyinterconnections of segments shown as angled may instead be curved.Accordingly, any of these various geometries may be configured to allowthe anchoring member 110 to conform to the native anatomy, resistmigration of the device 100, and mechanically isolate the valve support120 and/or the prosthetic valve 130 contained therein from forcesexerted on the anchoring member 110 by the native tissue.

The flexible characteristics of the individual ribs 114 can allow forthe flexibility and conformability of the anchoring member 110 to engageand seal the device 100 against uneven and uniquely-shaped nativetissue. Additionally, the flexibility can assist in creating a sealbetween the device 100 and the surrounding anatomy. FIG. 14A is aschematic top view of a native mitral valve MV illustrating the minoraxis 50 and major axis 55, and FIGS. 14B-14C are schematic top views ofan anchoring member 110 in an expanded configuration 102 and in adeployed configuration 104, respectively, overlaying the schematic ofthe native mitral valve MV in accordance with an embodiment of thepresent technology.

Referring to FIG. 14B, the upstream portion 112 (FIG. 10A) of theanchoring member 110 can have an outer circumference 150 with a diameterD₁ that is greater than the minor axis 50 (FIG. 14A) of the nativeannulus, and usually less than the major axis 55 of the annulus, whenthe anchoring member 110 is in an expanded configuration 102 (shown asdashed lines). In other embodiments, the anchoring member 110 may have adiameter D₁ at least as large as the distance between the nativecommissures C, and may be as large as or even larger than the major axis55 of the native annulus. In some embodiments, the outer circumference150 of the anchoring member 110 has the diameter D₁ which isapproximately 1.2 to 1.5 times the diameter (not shown) of the valvesupport 120 (or the prosthetic valve 130), and can be as large as 2.5times the diameter of the valve support 120 (or the prosthetic valve130). While conventional valves must be manufactured in multiple sizesto treat diseased valves of various sizes, the valve support 120 and theprosthetic valve 130, in accordance with aspects of the presenttechnology, may be manufactured in just a single diameter to fit amultitude of native valve sizes. For example, the valve support 120 andthe prosthetic valve 130 do not need to engage and fit the nativeanatomy precisely. In a specific example, the valve support 120 may havea diameter (not shown) in the range of about 25 mm to about 32 mm foradult human patients. Also in accordance with aspects of the presenttechnology, the anchoring member 110 may be provided in multiplediameters to fit various native valve sizes, and may range in diameterat an upstream end from about 28 mm to about 80 mm, or in otherembodiments, greater than 80 mm.

The top view of the anchoring member 110 shown in FIG. 14C illustrateshow flexibility and/or deformation of one or more longitudinal ribs 114and/or rib segments allows the anchoring member 110 to distort relativeto the expanded configuration 102, as shown by the dashed lines, into adeployed configuration 104, as shown by the bolded lines. As shown inFIG. 14C, the anchoring member 110, when deployed or implanted at orunder the mitral valve annulus, can conform to the highly variablenative mitral valve tissue shape MV, as shown in the dotted lines, whilethe ribs 114 bend, twist, and stretch such that the overall shape of theanchoring member 110 has a deployed (e.g., a generally more oval orD-shaped, or other irregular shape) configuration 104 instead of a fullyexpanded configuration 102. Referring to FIGS. 14B-14C together, theanchoring member 110 covers the mitral valve commissures C in thedeployed configuration 104, whereas the commissures C would be leftunsealed or exposed in the more circular expanded configuration 102,potentially allowing paravalvular leaks. The anchoring member 110 couldalso be pre-shaped to be in a generally oval or D-shape, or other shape,when in an unbiased condition.

FIG. 15 is an isometric view of an embodiment of the prosthetic heartvalve device 100 illustrated in a deployed configuration 104 inaccordance with an embodiment of the present technology. FIG. 15illustrates the device 100 having a plurality of ribs 114, wherein afirst set of ribs 160 can be configured to bend inwards or compresstoward the center longitudinal axis 101 of the device 100 and a secondset of ribs 162 can be configured to bend outwards or flex in responseto an distorting forces present in a subannular space of the nativevalve. As a result, the outer circumference 150 of the anchoring member110 may distort from a more circular shape in the expanded configuration102, as shown by the dashed line, to a generally more oval or D-shape inthe expanded configuration 104, as shown by the solid line, thusconforming to the shape of the native anatomy. In a further arrangement,the upstream portion 112 of the anchoring member 110 may be sizedslightly larger than the subannular space into which it is deployed,such that the anchoring member 110 is compressed to a slightly smallerdiameter in its deployed configuration 104. This may cause a slightrelaxation of the sealing member 142, such that sealing member sectionsbetween adjacent ribs 114 are sufficiently slack to billow or curveinwards or outwards to form a slack section Bi, as shown in FIG. 15.Such billowing can be desirable in some arrangements because thecurvature of the relaxed sleeve segment Bi can engage and conform to themitral leaflet tissue, thereby enhancing a seal formed between thedevice 100 and the native tissue.

As shown in FIG. 15, the unbiased, expanded configuration of the valvesupport 120, which in the illustrated embodiment is circular incross-section, remains substantially unaffected while the anchoringmember 110 conforms to the non-circular shape of the native mitral valveannulus MV. Accordingly, the valve support 120 is mechanically isolatedfrom these forces and maintains its structural shape and integrity. Themechanical isolation of the valve support 120 from the anchoring member110 may be attributed to several aspects of the prosthetic heart valvedevice 100. For example, the relative high flexibility of the anchoringmember 110 compared with the lower flexibility of the valve support 120allows the anchoring member 110 to deform significantly when deployedand when in operation (e.g., conform to the shape and motion of theanatomy under ventricular systole forces) while the valve support 120remains substantially undeformed (e.g., generally circular) in thesesame conditions. Additionally, radial spacing between the anchoringmember 110 and the valve support 120, particularly at the upstreamportion/upstream end where the anchoring member 110 engages the nativeannulus and/or subannular tissue, allows the anchoring member 110 to bedeformed inwardly a substantial amount without engaging the valvesupport 110. Further, the anchoring member 110 can be coupled to thevalve support 120 at a location (e.g. the downstream portion 111 of theanchoring member 110) which is spaced apart longitudinally a substantialdistance from the location (e.g., the upstream portion 112 of theanchoring member 110) at which the anchoring member 110 engages thenative annulus, allowing the ribs 114 of the anchoring member 110 toabsorb much of the distorting forces exerted upon it rather thantransmitting those forces directly to the valve support 120. Moreover,the coupling mechanisms employed to attach the anchoring member 110 tothe valve support 120 can be configured (e.g., to be flexible ormoveable) so as to reduce the transmission of forces from the anchoringmember 110 to the valve support 120 (discussed in more detail herein).

In many embodiments, the anchoring member 110 can have sufficientflexibility such that the anchoring member 110 conforms to the nativemitral annulus when in the deployed configuration 104 (FIGS. 14C and15); however, the anchoring member 110 can be configured to remainbiased towards its expanded configuration 102 (e.g., FIGS. 10A and 14B)such that, when in the deployed configuration 104, the anchoring member110 pushes radially outwards against the native annulus, leaflets,and/or ventricular walls just below the annulus. In some arrangements,the radial force generated by the biased anchoring member shape may besufficient to deform the native anatomy such that the minor axis 50(FIG. 14A) of the native valve is increased slightly, and/or the shapeof the annulus is otherwise altered. Such radial force can enhanceanchoring of the device 100 to resist movement toward the atrium whenthe valve 130 is closed during ventricular systole as well as movementtoward the ventricle when the valve 130 is open. Furthermore, theresulting compression fit between the anchoring member 110 and leafletsand/or ventricular walls or other structures helps create a long-termbond between the tissue and the device 100 by encouraging tissueingrowth and encapsulation.

FIGS. 16A-17C illustrate a prosthetic heart valve device 100 configuredin accordance with additional embodiments of the present disclosure.FIGS. 16A-16C include a top view and first and second side views of aprosthetic heart valve device 100 illustrated in an expandedconfiguration 102 that includes features generally similar to thefeatures of the prosthetic heart valve device 100 described above withreference FIGS. 10A-15. For example, the device 100 includes the valvesupport 120 and the prosthetic valve 130 housed within an interior lumenof the valve support 120. However, in the embodiment shown in FIGS.16A-16C, the device 100 includes an anchoring member 210 having an ovalor D-shaped upstream perimeter 213 and a plurality of elevations arounda circumference 250 of the anchoring member 210 such that the anchoringmember 210 is suitable for engaging and conforming with tissue in thesubannular region of the mitral valve.

Referring to FIGS. 16A-16C together, the device 100 can include theflexible anchoring member 210 at least partially surrounding and coupledto the valve support 120 at a downstream portion 211 of the anchoringmember 210. The device 100 can also include one or more sealing members140 extending around an inner wall 241 of the anchoring member 210and/or around the exterior surface 127 or the interior surface 126 ofthe valve support 120 to prevent paravalvular leaks between the device100 and the native tissue and/or between the anchoring member 210 andthe valve support 120. In one embodiment, the sealing member 140 canwrap around and/or cover the upstream perimeter 213 of the anchoringmember 210. For example, the sealing member 140 can be sewn, sutured, oradhered to a wall 241, 242 and have an extended portion (not shown) thatfolds over the upstream perimeter 213. In one embodiment, the sealingmember 140 can be adhered to an opposite wall (e.g., extend from theinner wall 241 to cover the upstream perimeter 213 and attached to anupper portion of the outer wall 242). However, in other embodiments, thesealing member 140 can have a longer free edge (not shown) leftunattached. The free edge of the sealing member 140 can be suitable insome arrangements to inhibit blood flow between the upper perimeter 213and the native tissue.

As illustrated in FIGS. 16B-16C, the anchoring member 210 has thedownstream portion 211 and an upstream portion 212 opposite thedownstream portion 111 along a longitudinal axis 201 of the device 100.Similar to the anchoring member 110 of device 100 (FIG. 10A), theupstream portion 212 of the anchoring member 210 can be a generallyoutward oriented portion of the device 100. In some embodiments, theanchoring member 110 can include of a series of circumferentiallypositioned, resiliently deformable and flexible ribs 214 which can be ina crisscross pattern around the circumference 250 of the anchoringmember 210 to form a diamond pattern. In one embodiment, the ribs 214can be flexible wires or filaments arranged in a diamond pattern orconfiguration. The diamond configuration can, in some embodiments,provide column strength sufficient to inhibit movement of the device 100relative the annulus under the force of systolic blood pressure againstthe valve 130 mounted in the valve support 120. In a particular example,the anchoring member 120 can be formed of a preshaped nitinol tubehaving, for example, a wall thickness of approximately 0.010 inches toabout 0.030 inches. The diamond pattern or configuration can, forexample, include one ore more rows of diamonds, and in some embodiments,between approximately 12 and approximately 36 columns of diamonds aroundthe circumference 250 of the anchoring member 210.

In some embodiments, the upstream perimeter 213 of the anchoring member210 does not lie in a single plane. For example, the ribs 214 can havevariable lengths and/or be off-set from each other at variable anglessuch that a distance (e.g., elevation) between a downstream perimeter215 and the upstream perimeter 213 can vary around the circumference250. For example, the upstream perimeter 213 can form a rim having aplurality of peaks 251 and valleys 252 (FIG. 16B) for adapting to theshape of the native mitral valve (see FIG. 5C). As used herein, “peaks”and “valleys” do not refer to diamond peaks and diamond valleys of adiamond pattern formed by the plurality of ribs 214, but refers toportions of the upstream perimeter 213 having an undulating shape formedby changes in elevation with respect to the downstream perimeter 215. Inone embodiment, the distance between the downstream perimeter 215 andthe upstream perimeter (e.g., elevation) can vary from about 6 mm toabout 20 mm, and in another embodiment, between about 9 mm and about 12mm.

In one embodiment, the upstream perimeter 213 of the anchoring member210 can have two peaks 251 that are separated by two valleys 252. Insome embodiments, a first peak can have a different shape or elevationthan that of a second peak. In other embodiments, the shape of a valley252 can be different than a shape of an inverted peak 251. Accordingly,the peaks 251 and valleys 252 can be asymmetrically positioned andshaped around the circumference 250 of the anchoring member 210. Invarious arrangements, the valleys 252 can be configured for positioningalong commissural regions of the native annulus, and the peaks 251 canbe configured for positioning along leaflet regions of the nativeannulus. In one embodiment, the peaks 251 can have apices configured tobe positioned near midpoint regions of the leaflets.

Referring to FIGS. 17A-17C, one specific example of the anchoring member210 can have a first elevation E₁ between the downstream perimeter 215and the upstream perimeter 213 of approximately 7 mm to about 8 mm atfirst and second regions 253, 254 of the anchoring member. The first andsecond regions 253, 254 are configured to align with the first andsecond commissures (e.g., anterolateral commissure AC and posteromedialcommissure PC, FIG. 5A) of the native mitral valve. The anchoring member210 can also have a second elevation E₂ between the downstream perimeter215 and the upstream perimeter 213 of approximately 9 mm to about 11 mmat a third region 255 of the anchoring member 210, wherein the thirdregion 255 is configured to align with an anterior leaflet AL (FIG. 5A)of the native mitral valve. The anchoring member 210 can further have athird elevation E₃ between the downstream perimeter 215 and the upstreamperimeter 213 of approximately 12 mm to about 13 mm at a fourth region256 of the anchoring member 210 opposite the third region 255, whereinthe fourth region 256 is configured to align with a posterior leaflet PL(FIG. 5A) of the native mitral valve. One of ordinary skill in the artwill recognize that the elevations E₁, E₂ and E₃ can have othermeasurements, and in some embodiments, the elevations E₁, E₂ and E₃ canbe different from one another or the same.

Additionally, the upstream perimeter 213 can form a rim having agenerally oval or D-shape, or other irregular shape for adapting to theshape of the native mitral valve. For example, and referring to FIG.17A, the upstream perimeter 213 of the anchoring member 210 can have amajor perimeter diameter D_(m1) and a minor perimeter diameter D_(m2)perpendicular to the major perimeter diameter D_(m1). In one embodiment,the major perimeter diameter D_(m1) is greater than the long axis MVA1of the native mitral valve (shown in FIG. 5C) when the device 100 is inthe expanded configuration 102 (FIG. 17A). In another embodiment, themajor perimeter diameter D_(m1) is less than the long axis MVA1 when thedevice 100 is in the expanded configuration 102. In such embodiments,the device 100 can be configured to have a major perimeter diameterD_(m1) that is greater than the long axis MVA1 when the device is in thedeployed configuration (e.g., when engaging the tissue on or under thenative annulus, see FIG. 16E). Further, the minor perimeter diameterD_(m2) can be greater than the short axis MVA2 of the native mitralvalve (shown in FIG. 5C) when the device 100 is in the expandedconfiguration 102 (FIG. 17A), or alternatively in the deployedconfiguration (FIG. 16E). In one embodiment, the major perimeterdiameter D_(m1) and/or minor perimeter diameter D_(m2) can beapproximately 2 mm to approximately 22 mm, or in another embodiment,approximately 8 mm to approximately 15 mm greater than the long axisMVA1 and/or the short axis MVA2, respectively, of the native mitralvalve. In some embodiments, the major perimeter diameter can beapproximately 45 mm to about 60 mm and the minor perimeter diameter canbe approximately 40 mm to about 55 mm.

Again referring to FIG. 16C, the upstream portion 212 of the anchoringmember 210 can be radially separated from the valve support 120 by a gap257. In one embodiment, the gap 257 is greater on an anterior leafletfacing side of the device 100 (e.g., along the third region 255) than ona posterior leaflet-facing side of the device 100 (e.g., along thefourth region 256).

Referring back to FIGS. 16A and 16C, the valve support 120 can beoriented along the first longitudinal axis 101 and the anchoring member210 can be oriented along the second longitudinal axis 201. The secondlongitudinal axis 201 can be off-set from the first longitudinal axis101. “Off-set” can refer to an arrangement where the axes 101, 201 areparallel but separated such that the gap 257 can vary around thecircumference 250 (FIG. 16C). FIG. 16D shows another embodiment in which“off-set” can refer to an arrangement wherein the second axis 201 can beangled from the first axis 101 (e.g., the first and second 101, 201 axesare non-collinear or non-parallel) such that the anchoring member 210 isgenerally tilted with respect to the valve support 120. In oneembodiment, the second longitudinal axis 201 is disposed at a tilt angleA_(TL) between 15° and 45° relative to the first longitudinal axis 101.

In additional embodiments, and as shown in more detail in FIG. 18, thefirst and second regions 253 and 254 of the upstream perimeter 213 canextend further from the longitudinal axis 201 than the third 255 andfourth regions 256. For example, the anchoring member 210 can have agenerally conical body (shown in dotted lines) and have upstream rimextensions 258 in the first and second regions 253 and 254. In someembodiments, the third region 255 of the upstream perimeter 213 canextend further from the longitudinal axis 201 than the fourth region256. In some arrangements, the third region 255 can have a size andshape that allows the anchoring member 210 to engage the inward facingsurface of the anterior leaflet without substantially obstructing theleft ventricular outflow tract (LVOT).

Referring to FIGS. 17A-17C together, the valve support 120 can beoriented along the longitudinal axis 101, and the upstream portion 212of the anchoring member 210 can flare outward from the longitudinal axis101 by a taper angle A_(T). In embodiments where the ribs 214 aregenerally curved outward from the downstream portion 211 to the upstreamportion 212 (rather than linear), the taper angle A_(T) can continuouslychange between the downstream portion and the upstream portion. In someembodiments, the taper angle A_(T) can be the same around thecircumference 250 of the upstream portion 212 of the anchoring member210; however, in other embodiments, the taper angle A_(T) can varyaround the circumference 250. For example, the anchoring member 210 canhave a first taper angle A_(T1) at the first and second regions 253 and254 (FIG. 17B) which can be configured to align with the anterolateralcommissure AC and posteromedial commissure PC (see FIG. 5C),respectively. The anchoring member 210 can further have a second taperangle A_(T2) at the third region 255 which can be configured to alignwith the anterior leaflet, and a third taper angle A_(T3) at the fourthregion 256 which can be configured to align with the posterior leaflet(FIG. 17C). In one embodiment, the taper angle can be approximately 30°to about 75°, and in another embodiment, between approximately 40° andabout 60°.

FIG. 16E is a schematic top view of a native mitral valve in the heartviewed from the left atrium and showing the prosthetic treatment device100 of FIG. 16A-16C implanted at the native mitral valve MV inaccordance with an embodiment of the present technology. Once deployed,and as illustrated in FIG. 16E, at least a portion of the upstream endsof the ribs 214 (shown in FIGS. 16B-16C) engage a subannular surface ofthe native valve (e.g., mitral valve). As described in more detailbelow, certain embodiments of ribs 114 or 214 are configured topenetrate subannular tissue to anchor and further stabilize the devices100.

Although the anchoring member 210 is deformable in response todistorting forces exerted by the native anatomy, the valve support 120can have sufficient rigidity to maintain a circular or other originalcross-sectional shape, thus ensuring proper functioning of theprosthetic valve leaflets 132 when opening and closing. Such mechanicalisolation from the anchoring member 210 may be achieved by the valvesupport 120 having sufficient rigidity to resist deformation whileanchoring member 210 is deformed, and by selecting a location and meansfor coupling the valve support 120 to the anchoring member 210 so as tomitigate the transmission of forces through the anchoring member 210 tothe valve support 120 or the prosthetic valve 130 contained therein. Forexample, the valve support 120 may be coupled to the anchoring member210 only at the downstream end 123 of the valve support 120, which isseparated from the upstream end 121 where the anchoring member 210engages the annulus. On the upstream end 121 of the anchoring member210, the valve support 120 may be completely unconnected to and spacedradially apart from the anchoring member 210 by the gap 257 to allowdeformation of the anchoring member 210 without impacting the shape ofvalve support 120 (see FIGS. 16A-16C where the prosthetic valve 130 islocated). Thus, forces exerted on the anchoring member 210 by theannulus can be absorbed by the flexible ribs 214 of the anchoring member210 to mitigate transmission of such forces to the downstream end 123 ofvalve support 120.

In some embodiments, it may be desirable to limit a distance the device100 extends downstream of the annulus into the left ventricle (e.g., tolimit obstruction of the left ventricle outflow tract (LVOT)).Accordingly, some embodiments of the device 100 can include anchoringmembers 210 having a relatively low overall elevation (e.g., elevationsE₁, E₂ and E₃, FIGS. 17B-17C), such that the anchoring member 210 doesnot extend into or obstruct the LVOT. As shown in the side view of FIG.16B, for example, the anchoring member 110 can have a low overallelevation E_(L) (e.g., the distance between the upstream perimeter 213and the downstream perimeter 215 of the anchoring member 210) withrespect to a height H_(V) of the valve support 120. In such embodiments,the upstream perimeter 213 of the anchoring member 110 may be justbelow, adjacent to, or positioned within the annulus of the nativemitral valve while the downstream perimeter 215 of the anchoring member210 is configured to extend minimally into the left ventricle below thenative mitral valve annulus when the device 100 is implanted. In somearrangements, the valve support 120 can be coupled to anchoring member210 so as to also minimize protrusion into the left ventricle, and insome embodiments, may extend upwardly through the plane of the nativeannulus into the left atrium.

Additional Components and Features Suitable for Use with the ProstheticHeart Valve Devices

Additional components and features that are suitable for use with theprosthetic heart valve devices (e.g., devices 100 described above) aredescribed herein. It will be recognized by one of ordinary skill in theart that while certain components and features are described withrespect to a particular device (e.g., device 100), the components andfeatures can also be suitable for use with or incorporated with otherdevices as described further herein.

As discussed above with respect to FIG. 10A, some embodiments of theprosthetic heart valve device 100 can include a sealing member 140 thatextends around portions of the anchoring member 110 and/or the valvesupport 120. For example, the embodiment illustrated in FIG. 10A has asealing member 140 around the inner wall 141 of the anchoring member 110and around an exterior surface 127 of the valve support 120 to preventparavalvular leaks both between the device 100 and the anatomy but alsothrough components of the device 100.

FIGS. 19A-19C are isometric, side and top views, respectively, of aprosthetic heart valve device 100 having a sealing member 140 inaccordance with a further embodiment of the present technology.Referring to FIGS. 19A-19C together, the device 100 includes a sealingmember 140, such as a skirt 144. The skirt 144 can be disposed on theouter wall 142 or disposed on the inner wall 141 and at least partiallyover the upstream perimeter 113 of the anchoring member 110.Accordingly, the skirt 144 can be fixed and/or coupled to any surface ofthe anchoring member 110. The skirt 144 can also overlay an interiorsurface 126 (shown in FIG. 19A) and/or exterior surface 127 of the valvesupport 120. Variations of the skirt 144 and/or other sealing members140 can be configured to (1) create a blood flow-inhibiting seal betweenthe anchoring member 110 and the native tissue, (2) block blood flowthrough the walls 141, 142 of the anchoring member 110 and/or throughthe surfaces 126, 127 of the valve support 120, and (3) block blood flowthrough the space between the valve support 120 and the anchoring member110. In some embodiments, the sealing member 140 can be configured topromote in-growth of adjacent tissue. The sealing member 140 can help toseal between the anchoring member 110 and the valve support 120, as wellas between the device 100 and the surrounding anatomy such that bloodflow is restricted to flowing through the prosthetic valve 130 from theleft atrium to the left ventricle. Additionally, the sealing member 140can provide circumferential support for the anchoring member 110 when inthe expanded configuration 102 (FIGS. 10A, 16A and 19A) or deployedconfiguration 104 (FIGS. 10B and 16B). In some embodiments, the sealingmember 140 may further serve to attach the anchoring member 110 to thevalve support 120. For example, the skirt 144 can be coupled to theinner wall 141 of the anchoring member 110 and integrally formed with orotherwise attached to the sealing member 140 that is coupled to thevalve support 120. In other embodiments, the sealing member 140 can beused to couple the valve support 120 to the prosthetic valve 130 housedin the interior of the valve support 120. Sealing members 140, such asskirts 144, can be coupled to the anchoring member 110 and/or valvesupport 120 with sutures, rivets or other known mechanical fasteners. Inother embodiments, adhesives, glues and other bonding materials can beused to couple the sealing members to components of the device 100.

FIG. 20A is an isometric view of a prosthetic heart valve device 100without a sealing member 140, and FIGS. 20B-20E are isometric views ofprosthetic heart valve devices 100 having sealing members 140 inaccordance with additional embodiments of the present technology. Forexample, FIGS. 20B-20C show embodiments of the device 100 in which thesealing member 140 is a sleeve 146. The sleeve 146 can include animpermeable sealing material that is cylindrical and configured to fitwithin or over various frame or skeleton structures of the device 100 asfurther described below. In FIG. 20B the sleeve 146 is on the exteriorsurface 127 of the valve support 120, whereas in FIG. 20C, the sleeve146 is also disposed on the inner wall 141 of the anchoring member 110and on the exterior surface 127 of the valve support 120. FIG. 20Dillustrates an embodiment of the device 100 in which the sleeve 146 isdisposed on the outer wall 142 of the anchoring member 110 and on theexterior surface 127 of the valve support 120. Referring to FIG. 20E,the device 100 can also incorporate the sleeve 146 on both the outerwall 142 and inner wall 141 of the anchoring member 110 as well as onthe exterior surface 127 of the valve support 120.

One of ordinary skill in the art will recognize that the sealing members140, such as the skirts 144 and sleeves 146 shown in FIGS. 19A-20E, canfully cover the walls 141, 142 or surfaces 126,127, or in otherembodiments, at least partially cover the walls 141, 142, and/or thesurfaces 126, 127 of the anchoring member 110 and the valve support 120,respectively. Any combination of sealing members 140 is contemplated.Additionally, the sealing member 140 can comprise a single continuoussheet of fluid impervious material (e.g., for covering the inner surface141 of the anchoring member 110 and the exterior surface 127 of thevalve support 120), which could create a seal between the anchoringmember 110 and the valve support 120. In various embodiments, thesealing member 140, such as the skirt 144 or sleeve 146, can comprise afabric or other flexible and biocompatible material such as Dacron®,ePTFE, bovine pericardium, or other suitable flexible material tointegrate with tissue and minimize paravalvular leaks. In otherembodiments, the sealing member 140 can include a polymer, thermoplasticpolymer, polyester, Gore-Tex®, a synthetic fiber, a natural fiber orpolyethylene terephthalate (PET). The valve 130 may also be attached tothe sealing member 140 or integrally formed with the sealing member 140.

In a further embodiment, shown in FIGS. 21A-21F, the valve support 120may comprise a tubular member 148 of fabric, polymer, or pericardiumwith little or no metallic or other structural support. Referring toFIGS. 21A-21B, the tubular member 148 may be a thicker and more rigidportion of a sleeve 146 which is capable of retaining its shape and hassufficient strength to resist radial and axially tensile forces duringsystole, and axial compressive forces during diastole. The leaflets 132of the prosthetic valve 130 may be integrally formed with, sewn orotherwise attached to the tubular member 148. In one embodiment, thetubular member 148 can be integrally formed with an outer portion 146Aof the sleeve 146 that extends around the anchoring member 110 (shown inFIG. 21A), or in another embodiment, the tubular member 148 can be aseparate and/or thicker member which is sewn, bonded, or otherwisefastened to the sleeve 146 in a blood-tight manner. The tubular member148 can optionally include reinforcing members to give it greaterstrength and to help it retain a desirable shape suitable for operatingthe valve 130. For example, a series of relatively stiff longitudinalstruts 190 of metal or polymer can be coupled to or embedded within thewalls of tubular member 148 (FIG. 21C), and/or a wire coil 192 mayextend around or be embedded within walls of the tubular member 148(FIG. 21D). In a further embodiment, a series of tethers 194 can becoupled between the outer portion 146A of the sleeve 146 and tubularmember 148 (FIG. 21E). In one arrangement, the tethers 194 can extend ata downstream angle from the upstream portion 112 of the anchoring member110 so as to inhibit collapse or structural compromise of the tubularmember 148 during atrial systole. In yet another embodiment, a pluralityof vertical septa 196 may be interconnected between the anchoring member110 (and/or a sealing member 140 coupled to the inner wall 141 of theanchoring member 110) and the tubular member 148 (FIG. 21F). Theplurality of vertical septa 196 coupled between the anchoring member 110and the valve support 120 can be a flexible fabric or polymer, and insome embodiments, can be the same material used for the sleeve 146. Thesepta 196, which can be collapsed with the anchoring member 110 to a lowprofile delivery configuration (not shown) can also constrain theoutward deflection of the ribs 114 when the device 100 is in theexpanded configuration 102.

As described herein, the anchoring member 110 can be a structure orcomponent separate from the valve support 120. In one embodiment, theanchoring member 110 can be coupled to the valve support 120 at, forexample, a downstream end 123 of the valve support 120, while theupstream portion of the anchoring member 110 can remain uncoupled to thevalve support 120 and/or other otherwise be mechanically isolated fromthe valve support 120. The anchoring member 110 can be coupled to thevalve support 120 using a variety of mechanisms, including flexible, ornon-rigid, coupling mechanisms. FIGS. 22A-22G and 22I-22K are enlargedside views of various mechanisms of coupling the valve support 120 tothe anchoring member 110 that allow relative movement between thedownstream portions or the anchoring member 110 and the valve support120 or otherwise provide mechanical isolation of the valve support 120from the anchoring member 110 in accordance with additional embodimentsof the present technology.

FIGS. 22A-22B illustrate a downstream end 326 of a rib 114 of theanchoring member 110 coupled to a post 122 of the valve support 120. Ina first embodiment, the rib 114 can be coupled to the post 122 by asuture, wire or other suitable filament 310 which is wrapped around theadjacent elements and tied (FIG. 22B). In some embodiments, either orboth the rib 114 and the post 122 may have a feature to which thefilament 310 may be secured, such as a through-hole 312 (FIG. 22C), aloop or eyelet 314 (FIG. 22D), or a groove 316 configured to retain thefilament 310 therein and inhibit sliding along the rib 114 or post 122.

In another embodiment shown in FIG. 22F, the rib 114 can be coupled tothe post 122 by a rivet, screw, pin, or other fastener 318 which passesthrough aligned holes 319 in the rib 114 and the post 122.Alternatively, and as shown in FIGS. 22G-22H, the post 122 may have acavity 320 in its outer wall configured to receive a downstream end 326of rib 144, and the two elements 114, 122 can be fastened together by afilament or fastener 322. In this arrangement, a substantial portion ofthe systolic force exerted on the valve support 110 can be translateddirectly to the rib 114 because the downstream end of the rib 114engages the floor of the cavity 320, thereby relieving the suture orfastener 322 from having to resist such force.

In further embodiments shown in FIGS. 22I-22J, a downstream end 326 ofthe rib 114 passes through a passage 324 formed through the post 122.The downstream end 326 is then secured to post 122 by a fastener 328 ora filament like those described above. Additionally, because the rib 114is held within the passage 324, the systolic loads exerted on the valvesupport 120 can be translated directly to the ribs 114 rather than tothe fastener 328. In yet another embodiment shown in FIG. 22K, adownstream end 330 of the post 122 is formed radially outward in a hookor J-shape, forming a channel 332 in which a downstream end 326 of therib 114 can be received. The ends 330, 326 of the two elements may besecured by a fastener 334 passing through holes 319 in the rib 114 andthe post 122. Systolic loads applied to the post 122 can be translateddirectly to the rib 114 via channel 332, relieving fastener 334 frombearing a substantial portion of the load.

FIGS. 23A-23B illustrate further embodiments of mechanisms suitable forcoupling the anchoring member 110 to the valve support 120. In theembodiments shown in FIGS. 23A-23B, circumferential connectors 116 ofthe anchoring member 110 are coupled to the struts 124 of the valvesupport 120. For example, in FIG. 23A, the connectors 116 are formed soas to have an hourglass-shaped portion 336 forming a waist 338 and anenlarged connector head 340 forming a connector cell 341. Struts 124similarly have an enlarged strut head 346 forming a strut cell 347. Thehourglass portion 336 of the connector 116 can be configured to passthrough the strut cell 347 such that the strut head 346 extends aroundthe waist 338 of the connector 116. The connector head 340 can besufficiently large that it is prevented from being released from thestrut cell 347. Further, due to the diverging angles of connectorsegments 116A, 116B, the strut head 346 can be prevented from slidingupward relative to the connector head 340. In such arrangements,systolic loads exerted in the upward direction on the valve support 120can be translated through the struts 124 to the connectors 116, which inturn translate these forces to the ribs 114 which are driven into thenative anatomy to anchor the device 100 in place.

In FIG. 23B, the connectors 116 can be formed so as to have a loopportion 348 extending downwardly which is nested in a concave portion350 formed in the strut 124. The loop portion 348 can be fastened to theconcave portion 350 in various ways, e.g. by a suture 352 wrapped aroundeach member 348, 350. In this arrangement, systolic loads applied tovalve support 120 in the upstream direction can be transferred throughthe concave portion 350 to loop portions 348 of the anchoring member110.

In other embodiments, the anchoring member 110, or selected componentsthereof, can be integrally formed with the valve support 120. As shownin FIG. 24A, the ribs 114 of the anchoring member 110 can be integrallyformed with posts 122 of the valve support 120 with a U-shaped bridgemember 356 interconnecting each rib 114 to respectively aligned posts122. The ribs 114 may be circumferentially interconnected by expandableconnectors 116 formed integrally therewith. Alternatively, in theembodiment shown in FIG. 24A, a plurality of separate bands or wires 358extend around the circumference 150 of the anchoring member 110 and areeach slideably coupled to the ribs 114, e.g. by extending through a hole360 formed in each individual rib 114. The flexible bands or wires 358permit ribs 114 to be collapsed inwardly to a low-profile deliveryconfiguration (not shown), while limiting the outward deflection of theribs 114 when in the expanded configuration 102. Alternatively, a tether361 of wire or suture may be coupled between the individual ribs 114 andthe posts 122 (shown in FIG. 24B) to limit the outward deflection of theribs 114 when in the expanded configuration 102.

In further embodiments, a sleeve 146 may be secured to the ribs 114 in amanner which limits the outward deflection of the ribs 114 when thedevice 100 is in the expanded configuration (shown in FIG. 24C). Thesleeve 146 may, for example, extend around the outer side of each rib114 as shown in FIG. 24C to constrain it from expanding outwardly beyonda predetermined limit. Optionally, the sleeve 146 may further include ahorizontal septum 359 extending between an inner portion 146B of thesleeve 146 that extends around the valve support 120 and an outerportion 146A of the sleeve 146 that extends around the anchoring member110. The horizontal septum 359 can more rigidly constrain the outwardflexion of the ribs 114. In some embodiments, the septum 359 can alsoseal the annular cavity 163 formed by the septum 359 between the innerportion 146B and the outer portion 146A to limit blood flow into thiscavity 163 and minimizing clot formation therein. Alternatively,openings (not shown) may be formed in the sleeve 146 downstream of theseptum 359 which can permit blood to flow into the enclosed cavity 163to form a region of clot, thereby limiting the deflection of the ribs114 and making the device more rigid and securely anchored. The septum359, which can be a flexible fabric, polymeric, or pericardial material,can be located at the upstream end of the device 100 as shown, or at alocation spaced further downstream from the upstream end 121 of thevalve support 120. In a further embodiment shown in FIG. 24D, eachindividual rib 114 can be constrained within a passage 364 formed in thesleeve 146 by suturing or bonding two layers of sleeve fabric together.In the expanded configuration 102, the movement of the ribs 114 can belimited relative to the sleeve 146.

FIG. 25A is a partial cross-sectional view of a prosthetic heart valvedevice 100 having an anchoring member 110 and a valve support 120, andFIG. 25B is an enlarged view of the designated box shown in FIG. 25A inaccordance with an embodiment of the present technology. As shown inFIGS. 25A and 25B, there can be a gap 108 between the valve support 120and lower portion 111 of the anchoring member 110. If the gap 108exists, the gap 108 can be protected by a sleeve 146 to prevent bloodfrom leaking between the anchoring member 110 and the valve support 120in either an upstream or downstream direction.

FIGS. 26A-26D are schematic cross-sectional views of prosthetic heartvalve devices 100 having atrial retainers 410 and implanted at a nativemitral valve MV in accordance with various embodiments of the presenttechnology. FIGS. 26A-26C show several embodiments of the device 100 inwhich the device 100 includes an atrial retainer 410 configured toengage a supra-annular surface of the annulus AN or other tissue withinthe left atrium to assist the native leaflets in preventing downstreammigration of the device 100 into the left ventricle. In thesearrangements, the annulus AN can be sandwiched between a topcircumference 150 of the anchoring member 110 and a bottom surface ofthe atrial retainer 410.

As shown in FIG. 26A, one embodiment of the device 100 can include theatrial retainer 410 coupled to or integrally formed with the inner valvesupport 120. The atrial retainer 410 can extend upstream through theannulus AN and into a supra-annular space within the atrium and engagethe supra-annular surface or other atrial tissue with an outwardlyextending flange 420. In another embodiment shown in FIG. 26B, theatrial retainer 410 can comprise a plurality of fingers 412 which may beformed integrally with or otherwise coupled to the valve support 120(e.g. comprising upward extensions of posts 122 or upward extensions ofthe anchoring member 110). The fingers 212 can be generally uncovered orexposed within the left atrium as illustrated in FIG. 26B; however, inanother embodiment, the fingers 412 can be covered with a sealing member(not shown) or other covering of fabric, polyMeric sheet, or pericardialtissue extending around the outside or inside surfaces of the fingers412 to form a conical shape to help seal the device 100 with the nativetissue on the atrial side of the annulus AN and to help funnel bloodinto the prosthetic valve 130 (FIG. 10A). The fingers 412 may alsoinclude circumferential struts (not shown) interconnecting the fingers412 to limit lateral deflection and enhance the stiffness of thefingers. The fingers 412 can include a resilient shape memory material(e.g., nitinol) such that the fingers can be straightened and deflectedinwardly for delivery and be released to an unbiased, radiallyprojecting outward position in the expanded configuration 102 as shown.For example, the fingers 412 can have finger tips 414 biased outwardlyand, in some arrangements, in the downstream direction in the expandedconfiguration 102. During delivery to a desired position within thenative mitral valve MV, the device 100 can be unsheathed in the distalor downstream direction (discussed in more detail below), such that thefingers 412 are first released to engage the atrial side of the valveannulus AN. This indexes the position of the device 100 relative to thenative valve to ensure that the anchoring member 110 is positioned onthe ventricular side of the native annulus AN but not overextended intothe ventricle when it is unsheathed and expanded.

The atrial retainer 410 may alternatively be an extension of theanchoring member 110. In one embodiment shown in FIG. 26C, the atrialretainer 410 can include a plurality of atrial loops 416, which,although depicted in a more vertical plane, may alternatively lie in aplane more parallel to the plane of the native annulus AN, and whichextend upstream through the annulus AN, then extend radially outwardlyto engage a supra-annular surface. The loops 416, which may compriseextensions of one or more ribs 114 of the anchoring member 110, caninclude a resilient shape-memory metal (e.g., nitinol) or other materialthat may be compressed into a low profile shape for delivery thenreleased to expand to the radially-extended configuration shown in FIG.26C. Similar to the device 100 of FIG. 26C, FIG. 26D is also across-sectional view of a prosthetic heart valve device 100 thatincludes an atrial retainer 410 formed by an extension of the anchoringmember 110. As shown in FIG. 26D, the atrial retainer 410 can include acylindrical portion 418 which extends upwardly from the anchoring member110 through the native annulus AN, with a flange 420 at the proximalregion which extends over the atrial side of the native annulus AN toengage the supra-annular surface. The flange 420 can include a resilientshape memory material (e.g., nitinol) that can be collapsed for deliveryand expand when deployed at the native mitral valve MV. The cylindricalportion 418 and flange 420 may be integrally formed with the anchoringmember 110, e.g. comprised of extensions of the ribs 114, or in anotherembodiment, can be coupled to one or more portions of the anchoringmember 110 and/or the valve support 120.

In other embodiments, the prosthetic heart valve device 100 can includeatrial extending features that assist in retaining the device 100 in adesired location within the native mitral valve, but do notsubstantially engage atrial or supra-annular tissue. For example, FIG.27 is a side view of an anchoring member 110 having a vertical portion422 at the upstream end 424 for engaging the annulus AN in accordancewith another embodiment of the present technology. The anchoring member110 can include the lower portion 111 and the upper flared portion 112which is positionable in a subannular location between the leaflets LFand downstream of the annulus AN. The upstream portion 112 can beexpandable to a dimension that is larger than a corresponding dimensionof the subannular tissue and/or inward facing leaflets LF. The verticalportion 422 can be fitted within the annulus orifice so as to engage theannulus AN around an entire upstream circumference 150 of the anchoringmember 110. The vertical portion 422 can be expandable to a dimensionthat is larger than a corresponding dimension of the annulus AN suchthat radial expansion of the vertical portion 422 presses outwardlyagainst the native tissue to assist retaining the device in the desiredlocation with the native mitral valve. Optionally, the anchoring member110 can also include a plurality of tissue engaging elements 170, suchas spikes. In one embodiment, the spikes (shown here as tissue engagingelements 170) can be distributed around the circumference 150 of theupper portion 112 of the anchoring member 110 and oriented such that thespikes can penetrate tissue in a subannular location and can beconfigured to help the anchoring member 110 resist movement in either anupstream or downstream direction.

Prosthetic Heart Valve Devices Having Stabilizing Members

FIG. 28 illustrates one embodiment of the prosthetic heart valve device100 in an expanded configuration 102 that further comprises one or morestabilizing members 501 to help stabilize the device 100 at the nativevalve site and, in some embodiments, prevent tilting or lateralmigration, or to inhibit upstream or downstream migration of the device100. In some embodiments, the stabilizing members 501 may comprise oneor more arms 510 extending from a lower or downstream portion 111 of theanchoring member 110. The arms 510 are configured to engage the nativetissue, e.g. the valve leaflets, subannular tissue, or ventricular wall,either inside or outside the native leaflets, depending on theconfiguration.

FIG. 29 is an enlarged schematic, side view of a prosthetic heart valvedevice having an extended arm in accordance with an embodiment of thepresent technology. As shown in FIG. 29, an individual arm 510 maycomprise an arm body 512, an arm extension 514, and an arm tip 516. Thearm body 512 has an arm body length L₁ and may connect to a post 511 ata first joint 508. The post 511 can be a valve support post 122, ananchoring member rib 114, and/or another feature of the device 100(e.g., strut 124 or connector 116). A first arm angle A_(A1) is formedby the intersection of the axes of post 511 and the arm body 512; thefirst arm angle A_(A1) selected such that the arm 512 is positionable sothat the tip 516 can engage the native tissue at a desired location,e.g. the subannular tissue or ventricular wall behind the nativeleaflets. FIGS. 30A-30C are enlarged partial side views of a prostheticheart valve device 100 having arms 510 coupled to the device at variousangles with respect to a longitudinal axis 101 of the device inaccordance with further embodiments of the present technology. In oneembodiment, the first arm angle A_(A1) can be about 10° to about 45°. Inother embodiments, the first arm angle A_(A1) can be an obtuse angle(FIG. 30A), generally perpendicular or approximately a 90° angle (FIG.30B), or an acute angle (FIG. 30C).

Referring back to FIG. 29, the arm body 512 can connect to the armextension 514 at a distal end of the arm body 512. The arm extension 514can have an arm extension length L₂ which can be selected or optimizedfor penetrating a desired distance into the native tissue, such as about0.5-2 mm. The arm extension 514 can extend from the arm body 212 atsecond arm angle A_(A2). The second arm angle A_(A2) can be formed bythe intersection between the arm extension 514 and arm body 512 and beselected to provide the desired angle of engagement with the nativetissue, such as about 100° to about 135°. In other embodiments, the armextension 514 may be parallel or collinear with the arm body 512 (notshown), or may be eliminated entirely. The arm extension 514 terminatesat the arm tip 516. In embodiments without an arm extension 514, the armtip 516 can be the most distal portion of the arm body 512 (not shown).

The arm 510 may have an arm height H_(A1) extending from the first joint508 to the most distal reaching point of the arm, which could be the armtip 516 (shown in FIG. 29) along an axis parallel to the longitudinalaxis 101 of the device 100. The arm height H_(A1) can be selected oroptimized such that the arm tip 516 engages a desired location in thesubannular anatomy when the device 100 is in a desired longitudinalposition relative to the native mitral valve (e.g., when the anchoringmember 110 is in engagement with the subannular tissue). The arm heightH_(A1) will depend upon of the overall height of the anchoring member110 and/or valve support 120 as well as the location of the joint 508.FIGS. 31A-31C are enlarged, partial side views of prosthetic heart valvedevices having arms 510 of various lengths (L₁+L₂), and accordinglyhaving variable heights H_(A1). As shown, the arm height H_(A1) may begreater than the overall height H_(D1) of the anchoring member 110(represented by rib 114) or valve support (FIG. 31A), be intermediatebetween the respective heights H_(D1), H_(V1) of the anchoring member110 (represented by rib 114) and the valve support 120 (represented bypost 122) (FIG. 31B), or be less than the overall height H_(D1) of boththe anchoring member 110 (represented by rib 114) and the valve support120 (FIG. 31C).

Additional details and embodiments regarding the structure andattachment of arms or other stabilizing members suitable for use withthe device 100 can be found in International PCT Patent Application No.PCT/US2012/043636, entitled “PROSTHETIC HEART VALVE DEVICES ANDASSOCIATED SYSTEMS AND METHODS,” filed Jun. 21, 2012, the entirecontents of which are incorporated herein by reference.

FIGS. 32A, 32B, 32C, and 32D are cross-sectional views of a heart withan implanted prosthetic heart valve device 100 having arms 510 adisposed on an inward-facing surface of the leaflets LF, and FIGS.32A-1, 32B-1, 32C-1 and 32D-1 are enlarged views of the arms 510 aengaging the inward-facing surface of the leaflets as shown in FIGS.32A, 32B, 32C and 32D, respectively. The embodiments of prosthetic heartvalve devices 100 illustrated in FIGS. 32A-32D-1 have arms 510 aconfigured to expand to a position radially inside the leaflets LF,radially outside the leaflets LF, or a combination of inside and outsidethe leaflets LF. For example, FIGS. 32A and 32A-1, show arms 510 aexpanding and engaging an inward surface of the leaflets LF and show thearms 510 a partially piercing the leaflets LF. In another exampleillustrated in FIGS. 32B and 32B-1, the arms 510 a may fully penetratethe leaflets LF. In a further example, the device 100 can incorporatearms 510 a that 1) completely penetrate the leaflets LF and 2) partiallypierce subannular tissue (FIGS. 32C and 32C-1). Referring to FIGS. 32Dand 32D-1, the device 100 can be configured to incorporate arms 510 athat fully penetrate both the leaflets LF and the annular tissue of themitral valve MV.

FIGS. 33A-33C are schematic views illustrating various embodiments oftissue engaging elements 170 for use with prosthetic heart valve devices100 in accordance with the present technology. Tissue engaging elements170 can include any feature that engaged tissue in an atraumatic manner,such as a blunt element, or which partially pierces or fully penetratescardiac tissue, such as a barb or spike. As used herein, “tissueengaging” refers to an element 170 which exerts a force on the tissue Tbut does not necessarily pierce the tissue T, such as being atraumaticto the tissue T, as shown in FIG. 33A. As used herein, “partiallypiercing” refers to a tissue engaging feature 170 which at leastpartially penetrates the tissue T but does not break through an oppositesurface S, as shown in FIG. 33B. As used herein, “fully piercing” refersto a tissue engaging feature 170 which can both enter and exit thetissue T, as shown in FIG. 33C. “Piercing” alone may refer to eitherpartial or full piercing. Tissue engaging elements 170 may take the formof spikes, barbs, or any structure known in art capable of piercingcardiac tissue, or alternatively, any blunt or atraumatic featureconfigured to apply pressure on the cardiac tissue without piercing thetissue. Further details on positioning of such elements is describedherein.

FIGS. 34A, 34B and 34C are cross-sectional views of a heart with animplanted prosthetic heart valve device 100 having arms 510 a withtissue engaging elements 170 disposed on an inward-facing surface of theleaflets LF, and FIGS. 34A-1, 34B-1 and 34C-1 are enlarged views of thearms 510 a engaging the inward-facing surface of the leaflets LF asshown in FIGS. 34A, 34B and 34C, respectively. As illustrated in FIGS.34A-34C-1, tissue engaging elements 170 can be incorporated on andextend from the arms 510 a in either a downstream direction (FIGS. 34Aand 34A-1), upstream direction (FIGS. 34B and 34B-1), or in both thedownstream and upstream directions (FIGS. 34C and 34C-1). In otherembodiments, the tissue engaging elements 170 can be incorporated on andextend from the components of the anchoring member 110 and/or the valvesupport 120 in either or both the upstream and downstream directions.

FIGS. 35A-35C are side views showing prosthetic heart valve devices 100implanted at a mitral valve MV (illustrated in cross-section) in adeployed configuration 104, wherein the devices have arms 510 b forengaging an outward-facing surface of the native leaflets LF inaccordance with various embodiments of the present technology. FIG. 35Ashows an embodiment of the device 100 that includes arms 510 bconfigured to extend from the downstream end of the device 100 (e.g.,the ventricular end of a device implanted at a native mitral valvedownstream of the leaflets) to reach behind the leaflets LF such thatthe leaflets LF are effectively sandwiched between the arms 510 b andthe outer wall 142 of the anchoring member 110. In another embodiment,and as shown in FIG. 35B, the arms 510 b may cause leaflets LF to foldupon themselves in the space between the arms 510 b and the outer wall142 of the anchoring member 110. In a further embodiment illustrated inFIG. 35C, the arms 510 b can also include the tissue engaging elements170. FIG. 35C-1 is an enlarged view of the arm 510 b having tissueengaging elements 170 for engaging the outward-facing surface of theleaflets LF as shown in FIG. 35C. As shown in FIG. 35C-1, the arms 510 bconfigured to engage an outside-facing surface of the native leaflets LFmay include tissue engaging elements 170 on an inside surface of thearms 510 b such that they are oriented toward the leaflet tissue.

In accordance with another embodiment of the present technology, FIG.36A is a side view showing a prosthetic heart valve device 100 implantedat a mitral valve MV (illustrated in cross-section). The device shown inFIG. 36A has arms 510 b for engaging an outward-facing surface of thenative leaflets LF and arms 510 a for engaging an inward-facing surfaceof the native leaflets LF. Inside/outside arms 510 a, 510 b may furthercomprise tissue engaging elements 170 on a radially inside surface orradially outside surface of the arms 510 a, 510 b, respectively, forengaging or piercing the leaflet tissue. The arrangement ofinside/outside arms 510 a, 510 b around a circumference of the device100 can alternate in a pre-designed pattern. For example, inside arms510 a can alternate with outside arms 510 b as shown in FIG. 36B, oralternatively, arms 510 a, 510 b may extend radially outward and/orradially inward randomly or at irregular intervals, depending onplacement of the device 100 and with respect to alignment with thenative posterior and anterior leaflets.

FIGS. 37A-37D are enlarged side views of additional embodiments of arms510 suitable for use with a prosthetic heart valve device 100 inaccordance with the present technology. For example, in FIGS. 37A-37D,the arms 510 can have a similar overall profile as a profile of theanchoring member 110. The anchoring member 110 can include ribs havingvarying shapes, sizes and/or outwardly or inwardly oriented rib segments85 for forming the overall anchoring member profile. Accordingly, thearms 510 can also have varying shapes, sizes and/or outwardly orinwardly oriented arm segments that mimic the anchoring member 110profile. In some arrangements, the embodiments shown in FIGS. 37A-37Dare configured to clamp leaflets LF and/or the annulus AN tissue betweenthe arms 510 and the ribs 114 so as to conform the leaflet tissue to theshape of the anchoring device 110 for enhanced sealing and anchoring ofthe device. For example, FIG. 37A illustrates one embodiment in whicharm extensions 514 and/or arm bodies 512 may partially mimic the shapeof the ribs 114 and/or rib segments 85, and FIG. 37B illustrates anotherembodiment in which arm extensions 514 and/or arm bodies 512 moreclosely follow the shape of the ribs 114. Embodiments encompassed byFIGS. 37A-37B can apply to outward surface engaging arms 510 b and/orinward surface engaging arms 510 a. Additionally, as shown in FIGS.37A-37B, the arm extensions 514 can extend radially outwardly so as tobe generally parallel with an upstream segment 85A of the rib 114. Thearm extension 514 can be configured to extend partially along the lengthof the rib 114 and/or rib segments 85 (FIGS. 37A and 37C) or fully alongthe length of the rib 114 and/or rib segments 85. In FIG. 37D, the arms510 have second arm extensions 518 connected to an upstream portion ofthe first arm extension 514 and extending outwardly so as to begenerally parallel to a second rib segment 85B and third rib segment85A.

In some embodiments, the prosthetic heart valve device 100 mayincorporate a plurality of arms 510 around a circumference of the device100; however, in other embodiments, the device may include the pluralityof arms in groupings (e.g., first and second groupings so as to engagethe posterior and anterior leaflets, respectively). Additionally, thearms 510 may extend from the anchoring member 110 and/or valve support120 independently of other components including other arms 510, such asshown in FIG. 38A. In other embodiments and as shown in FIG. 38B, thedevice 100 may further include at least one first arm 510 xinterconnected with at least one second arm 510 y by interconnecting armstruts 520. The arm struts 520 can be configured to be circumferentiallyexpandable and may connect all arms 510 (e.g., arm 510 x and 510 y) orone or more groups of arms 510. In some embodiments, the arm struts 520can limit the outward extension of the arms 510 x, 510 y away from thedevice 100.

In accordance with aspects of the present technology, the arms 510 canbe coupled to and/or extend from components of the device 100symmetrically and/or asymmetrically around the circumference 150 of thedevice 100. FIGS. 39A-39D are schematic top views of arm locationpatterns with respect to the ribs 114 of the anchoring member 110 (e.g.,as shown in FIG. 38A). The arms 510 can be interspersed with ribs 114(FIGS. 39A and 39C), in the same radial plane as the ribs 114 of theanchoring member 110 (FIG. 39B), or both interspersed and in plane withthe ribs 114 (FIG. 39D). Further, the arms 510 may be configured toextend outside the expanded outer circumference 150 of the anchoringmember 110 (FIG. 39B), inside the expanded outer circumference 150 ofthe anchoring member 110 (FIG. 39A), extend to the same outercircumference 150 of the anchoring member 110 (FIG. 39C), or acombination of these configurations (FIG. 39D).

In the above-described embodiments, the arms 510 may be configured toengage tissue independently of the deployment of anchoring member 110.For example, delivery catheters suitable for the delivery of theprosthetic heart valve devices 100 may be equipped with separatemechanisms operable to deploy the arms 510 and the anchoring members 110individually or otherwise independently of each other. In this way, theanchoring member 110 may be first released into engagement with thenative tissue so that the position of device 100 may be assessed andadjusted by the operator until the desired final position has beenattained. Following deployment and positioning of the anchoring member110, the arms 510 can be released to engage the tissue. Such deploymentsystems and methods are useful when the arms 510 are equipped withtissue engaging elements 170 which, once deployed, may prohibit anyrepositioning of the device 100. In some embodiments, the anchoringmember 110 will be equipped with atraumatic tissue engagement elements170 which do not penetrate tissue or inhibit device relocation once theanchoring member 110 has been deployed. Accordingly, some embodiments ofthe device 100 may be repositionable even with the anchoring member 110expanded so long as the arms 510 are constrained in an undeployedconfiguration, with the device 100 becoming permanently anchored onlywhen the arms 510 are released.

Alternatively or in addition to tissue engaging elements 170 present onthe arms 510 as described above, tissue engaging elements 170 may bepresent on other components of the device 100. FIGS. 40A-40E are sideviews of prosthetic heart valve devices 100 having tissue engagingelements 170 on varying structures of the device 100 in accordance withadditional embodiments of the present technology. For example, tissueengaging elements 170 can be incorporated on the ribs 114 of theanchoring member 110. FIG. 40A shows tissue engaging elements 170incorporated on the upper rib segment 85A, and FIG. 40B shows the tissueengaging elements 170 incorporated on lower rib segment 85B. FIG. 40Cillustrates an embodiment of the device having the tissue engagingelements 170 along the entire rib 114. The tissue engaging elements 170are shown in FIGS. 40A-40C schematically, but one of ordinary skill inthe art will recognize that the elements can be any of a variety oftissue engaging elements 170 described herein (e.g., atraumatic,partially piercing, fully penetrating, etc.), or in other embodiments, acombination of different types of tissue engaging elements 170.Additionally, the tissue engaging elements 170 are shown oriented in anupstream direction (e.g., to inhibit upstream migration of the device100); however, in other embodiments, the tissue engaging elements 170can be oriented in a downstream direction (e.g., to inhibit downstreammigration of the device 100), or in a combination of downstream andupstream oriented directions. The tissue engaging elements 170 can beincorporated symmetrically around a circumference of the device 100, orin other embodiments, the tissue engaging elements 170 can beincorporated asymmetrically. For example, in some embodiments, thetissue engaging elements 170 can be present on a side of the device 100aligned with the posterior leaflet, but be absent or have a differentarrangement on a side of the device 100 aligned with the anteriorleaflet such that the wall separating the aortic valve from the leftventricle will not be affected by the tissue engaging elements 170.

FIG. 40D illustrates an embodiment of the device 100 having tissueengaging elements 170, such as spikes on an upstream tip 175 of the rib114, wherein the spikes can be configured to fully or partiallypenetrate subannular tissue when the device 100 is deployed on or underthe annulus of the mitral valve. In some embodiments, the tissueengaging elements 170 (e.g., spikes) can include barbs 176 or otherfeatures for retaining the tissue engaging elements 170 (e.g., spikes)in the tissue. In other embodiments, the tissue engaging elements 170(e.g., spikes) can be blunt so as to engage but not penetrate thesubannular tissue. FIGS. 40E-40G are enlarged side views of tissueengaging elements 170 (e.g., spikes) suitable for use on upstream tips175 of the ribs 114. Devices 100 having tissue engaging elements 170 onthe upstream tips 175 can also incorporate features for limiting thedistance of penetration into the tissue. For example, the upstream tip175 can have a hilt 177 formed a short distance, e.g. 1-5 mm, proximalto the tip of each tissue engaging element 170 to limit the distance towhich the tissue engaging element 170 can penetrate the subannulartissue (FIG. 40E). Alternatively, as shown in FIG. 40F, the depthpenetration of the tissue engaging element 170 into the tissue can belimited by positioning connectors 116 a desired distance from the tipsof the tissue engaging element 170. In a further embodiment shown inFIG. 40G, a sealing member 140 may be attached to the ribs 114 such thatthe upstream edge 178 of the sealing member 140 can limit the depth ofpenetration of the tissue engaging element 170. In order to preventslippage of the sealing member 140 downward, an attachment feature suchas a hole 173 configured to receive a suture may be formed in the rib114 at the desired distance from its upstream tip 175 to which thesealing member 140 can be firmly secured.

Alternatively, tissue engaging elements 170, such as bumps, ridges, orother protrusions configured to exert frictional forces on cardiactissue, may be also present on one or more valve support struts 124,valve support posts 122, and/or other components (e.g., sealing members140). These tissue engaging elements 170 can be disposed on an outerportion of these features and can be configured to extend outwardly toengage the native leaflets and to stabilize and firmly anchor the device100 in the desired location. Alternatively, ridges, scales, bristles, orother features having directionality may be formed on the surface of theribs 114, connectors 116, or sealing member 140 to allow movementrelative to native tissue in one direction, while limiting movement inthe opposite direction.

The tissue engaging elements 170 on the anchoring member 110 can bebarbs, spikes, or other retention features configured to have a delayeddeployment so as to allow the device to be repositioned or removed for aperiod of time until these elements become fully deployed. For example,the tissue engaging element 170 may be constructed of a shape memorymaterial (e.g., nitinol) which is preshaped in a deployed configurationand adapted to retain the tissue engaging element 170 in the nativetissue. The tissue engaging element 170 may be deformed into acontracted configuration which permits removal from tissue, and retainedin this shape by a bioerodable material or adhesive. Once immersed intissue, this material can erode over a period of time (e.g., 10minutes-2 hours) allowing the tissue engaging element 170 to return toits unbiased deployed shape which will assist in retaining the tissueengaging element 170 in the tissue.

Several examples of such delayed, deployable tissue engaging elements170 are shown in FIGS. 40I-40T. In the embodiment of FIG. 40I, thetissue engaging element 170 comprises a shape memory alloy shaft 450laser cut so as to have a diamond-shaped window 451 near its distal tip452, which can be sharp enough to penetrate tissue. The shape set sothat window 451 is biased toward being open in an expanded configurationas shown in FIG. 40I. Prior to delivery of the device, window 451 may bepinched closed and a bioerodable glue 455 may be injected into window451 to hold it in a closed configuration as shown in FIG. 40J. Upondeployment of the device, the distal tip 452 can penetrate the nativetissue, e.g. valve leaflet or annulus, as shown in FIG. 40K. The glue455 within window 451 maintains it in a closed configuration for aperiod of time to allow the operator to reposition or remove the deviceif necessary. If left in position, the glue 455 erodes, allowing thewindow 451 to reopen into the expanded configuration which will retainthe tissue engaging element 170 in the tissue as shown in FIG. 40L.

In the embodiment shown in FIGS. 40M-40P, the tissue engaging element170 comprises an arrowhead-shaped tip 453 having two or more wings 454biased to be angled radially outward and pointing in a proximaldirection as shown in FIG. 40M. A bioerodable glue or coating 455 isapplied over the arrowhead tip 453 to hold the wings 454 in a radiallycontracted configuration as shown in FIG. 40N. In the contractedconfiguration, the device 100 is deployed such that the tissue engagingelement 170 pierces the native tissue as shown in FIG. 40O. Thebioerodable coating 455 then erodes gradually until it allows the wings454 to return to the laterally expanded configuration shown in FIG. 40P,thus retaining the tissue engaging element 170 in the tissue.

A further embodiment is shown in FIGS. 40Q-40T. In this embodiment, thetissue engaging element 170 comprises a helical tip 456 in an unbiasedstate. A bioerodable coating 455 may be used to retain the helical tip456 in a straightened configuration as shown in FIG. 40R. The tissueengaging element 170 can penetrate the tissue in the contractedconfiguration, and when the bioerodable coating 455 erodes sufficientlyto allow the helical tip 456 to return to its deployed configuration,the tissue engaging element 170 can be retained in the tissue.

The prosthetic heart valve device 100 can also be configured to haveadditional tissue engaging elements 170 for engaging the annulus. Forexample, FIG. 41 is an isometric view of a prosthetic heart valve device100 having a plurality of annulus engaging elements 179 in accordancewith a further embodiment of the present technology. The annulusengaging elements 179 can be a C-shaped hook feature or other shape thatallows the element 179 to engage tissue on the annulus, as well as aportion of supra-annular tissue and subannular tissue. As shown, theannulus engaging elements 179 can be symmetrically (shown in FIG. 41) orasymmetrically interspersed around the upstream perimeter of theanchoring member 110 and coupled to ribs 114, connectors 116 (notshown), or to a sealing member 140. The annulus engaging elements 179may also be coupled to the anchoring member 110 at other locationsdownstream of the upstream perimeter 113, or in other embodiments to aportion of the valve support 120 that extends through at least theannulus plane PO (FIG. 3). Additionally, the annulus engaging elements179 may be blunt (e.g., for pressing but not penetrating into theannular tissue), or they may be sharp for penetrating the annulus tissueon either or both of the supra-annular or subannular surfaces. Theannulus engaging element 179 can be suitable for both positioning thedevice 100 in the desired location (e.g., with anchoring member 110below the annulus), as well as to inhibit movement of the device ineither an upstream or downstream direction.

In another embodiment shown in FIGS. 42A-42B, a prosthetic heart valvedevice 100 can have tissue engaging elements 372 deployable from aplurality of tubular ribs 314. Referring to FIG. 42A, the prostheticheart valve device 100 can have an anchoring member 110 having aplurality of tubular ribs 314 configured to retain a plurality ofdeployable tissue engaging elements 372. FIG. 42B is an enlarged view ofthe tubular rib 314 and a deployable tissue engaging element 372retained within a lumen 316 of the rib 314 and shown before deploymentof the element 372. The tissue engaging element 372 can comprise a shapememory material (e.g., nitinol) configured to deploy to a preformedshape upon release of the tissue engaging element 372 from the innerlumen 316 of the rib 314. Release of the tissue engaging element 372 canbe achieved by engaging a proximal end 374 of the tissue engagingelement 372. For example, the proximal end 374 can be engaged during thedeployment of the device 100 to release the tissue engaging element 372after the anchoring member 110 is positioned at the desired locationbelow the annulus AN. The tubular rib 314 can include a U-shapeddeflector 318 and a pivot point 320 configured to guide the tissueengaging element 372 distally through a distal opening 315 of the rib314. As illustrated in dotted lines in FIG. 42B, engagement of theproximal end 374 of element 372 will encourage a distal end 376 of thetissue engaging element 372 from the distal opening 315 of the tubularrib 314 to penetrate adjacent subannular tissue. Once deployed and afterexiting an opposing surface S, such as the supra-annular surface, thetissue engaging element 372 can transition into its preformed shape,such as a curled shape 378 that can resist retraction of the distal end376 from the tissue.

In accordance with another embodiment of the prosthetic treatment device100, tissue engaging elements 170 can be incorporated into sealingmembers 140 (e.g., sleeve 146). FIGS. 43A-43B are an isometric view andan enlarged detail view of a prosthetic heart valve device 100 having asealing member 140 configured with tissue engaging elements 170.Referring to FIGS. 43A-43B together, the tissue engaging elements 170can comprise metallic or polymeric wires 274 or fibers, rigid and sharpenough to penetrate tissue, which are woven into or otherwise coupled tosealing member 140 materials. The sealing member 140 can then beattached to outer and/or inner walls 141, 142 of the anchoring member110 and/or interior and/or exterior surfaces 126, 127 of the valvesupport 120 such that tissue engaging elements 170 extend radiallyoutward from the sealing member 140 to engage the adjacent leaflets orother tissue.

FIGS. 44A-44F are enlarged side views of embodiments of additionaltissue engaging elements that can be incorporated on various devicestructures (referred collectively as “ST”), such struts, connectors,posts, arms, and/or ribs which may be incorporated into device features,such as the anchoring member 110 or valve support 120. For example, theadditional tissue engaging elements may comprise one or more cut-outprotrusions 350 (FIGS. 44A and 44B) in place of or in addition to tissueengaging elements 170. In a collapsed or straightened configuration, asshown by the side view of FIG. 44C, cut-out protrusion 350 maintains lowrelief relative to the surface of structure ST to maintain a low profileduring delivery. As the device 100 expands and structure ST changes toits deployed configuration (e.g. a curvature as shown in FIG. 44D), theprotrusion separates from the ST to a higher relief. The protrusion 350may also be configured to grab subannular tissue, pulling the cut-outprotrusions even farther away from structure ST. The device structuresST may also be shaped to include sharp protrusions 352 along one or moreof its edges or faces, as illustrated in FIG. 44E, or may also includepointed scale-like protrusions 354, as shown in FIG. 44F.

In addition to the stabilizing members 501 described above, theprosthetic heart valve devices described herein (e.g., devices 100) mayalso include support features such as tethers 360 and sealing membersepta 370 for stabilizing the anchoring member 110 and/or the valvesupport 120, and/or for spreading pressure gradient loads evenly over agreater area of the device 100 (e.g., during ventricular systole).Referring to FIG. 45A, one example of the device 100 can incorporate aplurality of tethers 360 at least loosely coupling the upper portion 112of the anchoring member 110 to the upstream end 121 of the valve support120. In one embodiment, the tethers 360 can include a single suture thatis run continuously around the circumference 150 of the anchoring member110. In another embodiment, the device 100 can include several suturesof discreet lengths tied between the anchoring member 110 and the valvesupport 120. In one embodiment the tethers can be a suture comprisingpolytetrafluoroethylene (PTFE). Generally, the tethers 360 assist indistributing forces evenly along the anchoring member 110 withoutdeforming the valve support 120 or compromising the closure of theprosthetic valve 130. In some arrangements, the tethers 360 can assistin limiting radial expansion of the upstream portion. Accordingly, evenwith the incorporation of the tethers 360, the valve support 120 remainsmechanically isolated from at least the upstream portion of theanchoring member 110.

FIG. 45B shows another example of a stabilizing member 501 suitable tostabilize the anchoring member 110 and/or the valve support 120, and/orfor spreading pressure gradient loads evenly over a greater area of thedevice 100 (e.g., during ventricular systole). As shown in FIG. 45B, thedevice 100 can include a plurality of sealing member septa 370 extendingbetween the anchoring member 110 and the valve support 120. In theillustrated embodiment, the septa 370 can be extensions of the sealingmember material configured to span between a sealing member 140, such asa skirt 144, coupled to the inner wall 141 of the anchoring member 110and a sealing member 140, such as a sleeve 146, coupled to an interioror exterior surface 126, 127 of the valve support 120. Accordingly, thesepta 370 can be formed of fabric or other flexible and biocompatiblematerials such as Dacron®, ePTFE, bovine pericardium, or other suitablematerials. Similar to the embodiment illustrated in FIG. 45A, the septa370 can assist in distributing forces evenly along the anchoring member110 without deforming the valve support 120 or otherwise compromisingthe closure of the prosthetic valve 130. In some arrangements, the septa370 can assist in preventing the device 100 from everting duringventricular systole. Accordingly, even with the incorporation of thesepta 370, the valve support 120 is mechanically isolated from at leastthe upstream portion of the anchoring member 110.

Each of the elements and members of the device 100 may be made from anynumber of suitable biocompatible materials, e.g., stainless steel,nickel titanium alloys such as Nitinol™, cobalt chromium alloys such asMP35N, other alloys such as ELGILOY® (Elgin, Ill.), various polymers,pyrolytic carbon, silicone, polytetrafluoroethylene (PTFE), or anynumber of other materials or combination of materials depending upon thedesired results. The arm members 510, sealing member 140, sleeves 146,anchoring member 110 and/or valve support 120 or other elements ofdevice 100 may also be coated or covered with a material that promotestissue in-growth (e.g., Dacron®, PTFE, etc.)

Delivery Systems

FIGS. 46A-46D illustrate one embodiment of a delivery system 10 suitablefor delivery of the prosthetic heart valve devices disclosed herein. Asused in reference to the delivery system, “distal” refers to a positionhaving a distance farther from a handle of the delivery system 10 alongthe longitudinal axis of the system 10, and “proximal” refers to aposition having a distance closer to the handle of the delivery system10 along the longitudinal axis of the system10.

FIG. 46A illustrates one embodiment of the delivery system 10 which maybe used to deliver and deploy the embodiments of the prosthetic heartvalve device 100 disclosed herein through the vasculature and to theheart of a patient. The delivery system 10 may optionally include aguiding catheter GC having a handle 12 coupled to a delivery shaft 16,which in one embodiment is 34F or less, and in another embodiment, 28For less in diameter. The guiding catheter GC may be steerable orpreshaped in a configuration suitable for the particular approach to thetarget valve. The delivery catheter 18 is placed through a hemostasisvalve HV on the proximal end of guiding catheter GC and includes aflexible tubular outer shaft 19 extending to a delivery sheath 20 inwhich the device 100 is positioned in a collapsed or deliveryconfiguration 106. A flexible inner shaft 28 is positioned slideablywithin outer shaft 19 and extends through the device 100 to a nosecone21 at the distal end. The inner shaft 28 has a guidewire lumen throughwhich a guidewire 24 may be slideably positioned. The device 100 iscoupled to the inner shaft 28 and is releasable from the inner shaft 28by release wires 30, as more fully described below. The delivery sheath20 can protect and secure the device 100 in its collapsed configuration106 during delivery. The outer shaft 20 is coupled to a retractionmechanism 23 on the handle 14 of the delivery catheter 18. Variousretraction mechanisms 23 may be used, such as an axially-slidable lever,a rotatable rack and pinion gear, or other known mechanisms. In thisway, the outer shaft 20 may be retracted relative to the inner shaft 28to release (e.g., deploy) the device 100 from the sheath 20.

FIG. 46B shows the distal end of the delivery catheter 18 with thesheath 20 cut away to illustrate the coupling of the device 100 to theinner shaft 28. A plurality of locking fingers 32 are coupled to thenose cone 21 and extend proximally through the interior of the valvesupport 120 of the device 100. As shown in FIG. 46C, a selected numberof posts 122 of the valve support 120 have a coupling element 61comprising a tab 34 cut out from each post 122 at a proximal endthereof. The tab 34 may be deflected inwardly from the post 122 as shownin FIG. 46B and is configured to extend through a window 42 in thelocking finger 32 as shown in FIG. 46D. The release wires 30 passthrough the holes 40 in the tabs 34, which prevents the tabs 34 frombeing withdrawn from the windows 42 to secure the device 100 to theinner shaft 28. The pull-wires 30 can be sandwiched tightly between thetabs 34 and the locking fingers 32, such that friction temporarilyprevents the pull-wire 30 from slipping in a proximal or distaldirection. In this way, the sheath 20 may be retracted relative to thedevice 100 to permit expansion of the device 100 while the inner shaft28 maintains the longitudinal position of the device 100 relative to theanatomy. The pull-wires 30 may extend proximally to the handle 14, forexample, in between the inner shaft 28 and the outer shaft 19 or withinone or more designated lumens. A suitable mechanism (not shown) on thehandle 14 can allow the operator to retract the release wires 30 in aproximal direction until they are disengaged from the tabs 34.Accordingly, the device 100 can be released from the locking fingers 32and expand for deployment at the target site.

FIGS. 47A-47D are schematic, cross-sectional side views of a heart Hshowing a trans-septal or antegrade approach for delivering anddeploying a prosthetic heart valve device 100. As shown in FIG. 47A, aguidewire 24 may be advanced intravascularly using any number oftechniques, e.g., through the inferior vena cava IVC or superior venacava SVC, through the inter-atrial septum IAS and into the right atriumRA. The guiding catheter GC may be advanced along the guidewire 24 andinto the right atrium RA until reaching the anterior side of the atrialseptum AS, as shown in FIG. 47B. At this point, the guidewire 24 may beexchanged for the needle 25, which is used to penetrate through theinter-atrial septum IAS (FIG. 47C). The guiding catheter GC may then beadvanced over the needle 25 into the left atrium LA, as shown in FIG.47D. The guiding catheter GC may have a pre-shaped or steerable distalend to shape or steer the guiding catheter GC such that it will directthe delivery catheter 18 (FIG. 46A) toward the mitral valve.

As an alternative to the trans-septal approach, the mitral valve mayalso be accessed directly through an incision in the left atrium. Accessto the heart may be obtained through an intercostal incision in thechest without removing ribs, and a guiding catheter may be placed intothe left atrium through an atrial incision sealed with a purse-stringsuture. A delivery catheter may then be advanced through the guidingcatheter to the mitral valve. Alternatively, the delivery catheter maybe placed directly through an atrial incision without the use of aguiding catheter.

FIGS. 48A-48C are cross-sectional views of the heart illustrating amethod of implanting a prosthetic heart valve device 100 using atrans-septal approach. Referring to FIGS. 48A-48C together, the distalend 21 of the delivery catheter 18 may be advanced into proximity to themitral valve MV. Optionally, and as shown in FIG. 48A, a guidewire GWmay be used over which catheter 18 may be slideably advanced over aguidewire GW. The sheath 20 of the delivery catheter 18, which containsthe device 100 in a collapsed configuration 106, is advanced through themitral valve annulus AN between native leaflets LF, as shown in FIG.48A. Referring to FIG. 48B, the sheath 20 is then pulled back proximallyrelative to the distal nose cone 27 allowing the device 100 to expandsuch that anchoring member 110 pushes the leaflets LF outwardly to foldbeneath the mitral valve annulus AN. The tips of the ribs 114 engage andmay penetrate into or through the leaflet tissue to further engage thetissue of the annulus AN. After the sheath 20 has been removed and thedevice 100 allowed to expand, the delivery system can still be connectedto the device 100 (e.g., system eyelets, not shown, are connected to thedevice eyelets 180, shown in FIG. 10A) so that the operator can furthercontrol the placement of the device 100 in the expanded configuration102. For example, the device 100 may be expanded upstream or downstreamof the target location then pushed downstream or upstream, respectively,into the desired target location before releasing the device 100 fromdelivery system 10. Once the device 100 is positioned at the targetsite, the pull-wires 30 (FIGS. 46A-46B) may be retracted in a proximaldirection, to detach the device 100 in the deployed configuration 104from the delivery catheter 18. The delivery catheter 18 can then beremoved as shown in FIG. 48C. Alternatively, the device 100 may not beconnected to the delivery system 10 such that the device 100 deploys andis fully released from the delivery system 10.

FIGS. 49A and 49B illustrate another variation for delivering anddeploying one or more prosthetic heart valve devices 100 using aretrograde approach to the mitral valve via the aorta and leftventricle. In this example, the guidewire GW may be advancedintravascularly from a femoral or radial artery or through direct aorticpuncture through the aorta AO and aortic valve AV, and into the leftventricle LV of the heart H (FIG. 49A). A guiding catheter GC, oralternatively, the delivery catheter 18, may be advanced along theguidewire GW until the distal end is positioned within the leftventricle in proximity to the mitral valve MV, as shown in FIGS. 49A and49B. In many arrangements, the guiding catheter GC and/or the deliverycatheter 18 will have a steering mechanism or a pre-shaped distal tipallowing it to be steered around the 180° turn from the aortic valve AVto the mitral valve MV. The distal end of the delivery catheter 18 mayoptionally be advanced at least partially through the mitral valve MVinto the left atrium LA.

FIGS. 50A-50B illustrate delivery of the device 100 in the collapsedconfiguration 106 to the mitral valve MV in a trans-apical approach.Referring to FIG. 50A, the delivery catheter 18 is advanced through aguiding catheter GC that has been inserted into the left ventricle ofthe heart through a puncture in the left ventricle wall at or near theapex of the heart. The catheter can be sealed by a purse-string suture.Alternatively, the delivery catheter 18 may be placed directly through apurse-string-sealed trans-apical incision without a guiding catheter.The sheath 20 and the device 100 (e.g., in the collapsed configuration106) within the sheath 20 are advanced through the mitral annulus ANbetween native leaflets LF as shown in FIG. 50A. Referring to FIG. 50B,the sheath 20 is pulled proximally such that the device 100 expands tothe expanded and/or deployed configurations 102, 104. The deliverysystem 10 can remain connected to the device 100 (e.g., system eyelets,not shown, are connected to the device eyelets 180, FIG. 10A) afterremoving the sheath 20 so that the operator can control the placement ofthe device 100 while in the expanded configuration 102. The pull-wires30 may be retracted in a proximal direction to release the device 100from the delivery system 10, allowing the delivery system 10 to beremoved and the device to be fully implanted at the mitral valve MV inthe deployed configuration 104. In one embodiment, the device 100 may beexpanded upstream or downstream of the desired target location thenpulled or pushed downstream or upstream, respectively, into the targetlocation before releasing the device 100 from delivery system 10.Alternatively, the device 100 may not be connected to the deliverysystem 10 such that the device 100 deploys and is fully released fromthe delivery system 10.

FIGS. 51A-51B are partial side views of a delivery system 10 wherein aprosthetic heart valve device 100 is mounted on an expandable balloon300 of a delivery catheter 18 in accordance with another embodiment ofthe present technology. Referring to FIGS. 51A and 51B together, thedevice 100 can be mounted on an expandable balloon 300 of a deliverycatheter while in a collapsed configuration 106 and delivered to thedesired location at or near a native mitral valve (FIG. 51A). When thedevice 100 is released from the sheath 20 (FIGS. 46A-46B), the device100 can be expanded to its expanded configuration 102 by inflation ofthe balloon 300 (FIG. 51B). When using a balloon 300 with the deliverysystem 10, the device 100 can be advanced from the delivery shaft 16 toinitially position the device 100 in a target location. The balloon 300can be inflated to fully expand the device 100. The position of thedevice 100 relative to the mitral valve may then be adjusted using thedevice locking hub to position the device into desired implantation site(e.g., just below the annulus of the native mitral valve). In anotherembodiment, the balloon 300 can initially be partially inflated topartially expand the device 100 in the left atrium. The delivery system10 can then be adjusted to push or pull (depending on the approach) thepartially expanded heart valve device 100 into the implantation site,after which the device 100 can be fully expanded to its functional size.In other alternative methods, the anchoring member 110 is aself-expanding construct which is first released from a sheath 20 (FIGS.46A-46B) at the target site to engage the native anatomy, while thevalve support 120 is a balloon-expandable element mounted on a balloon300 which is then expanded to fully deploy the valve support 120 afterthe anchoring member 110 has been released.

In still further embodiments, the valve support 120 of device 100 may beconfigured to be axially movable or detachable from the anchoring member110. In such arrangements, the two components 110, 120 may be loaded inan axially separated configuration within the delivery system 10,thereby reducing the overall profile of the system 10. After delivery tothe target valve site, the components 110, 120 can be assembledtogether. FIGS. 52A-52D show an embodiment of assembling the valvesupport 120 and anchoring member 110 in the heart. As shown in FIG. 52A,the delivery catheter 380 is advanced into the left atrium via a guidingcatheter GC placed through the inter-atrial septum or the atrial wall.The delivery catheter 380 has a split sheath 382, 384 comprising adistal nose cone 382 and a proximal capsule 384. The delivery catheter380 is advanced through the native valve MV until the nose cone 382 ispositioned distally of the native annulus AN (FIG. 52A). The nose cone382 is then advanced further distally while maintaining the position ofthe remainder of the delivery catheter 380 thereby releasing theanchoring member 110 from the nose cone 382 (FIG. 52B). The anchoringmember 110 self-expands outward, engaging the native leaflets LF andfolding them outward beneath the native annulus AN, as shown in FIG.52B. The upstream tips of ribs 114 (FIG. 52B) engage the subannulartissue to anchor the device 100 in position. The sealing member 140 isfixed around the perimeter 113 of the anchoring member 110 and has aconnecting portion 386 extending into the proximal capsule 384 where itis fixed to the valve support 120, which is still constrained within theproximal capsule 384. The delivery catheter 380 is then advanced so asto position the proximal capsule 384 within the anchoring member 110 asshown in FIG. 52C. By advancing the catheter 380 until the sealingmember 140 becomes taught, the proper positioning may be attained. Theproximal capsule 384 is then retracted relative to the nose cone 382 torelease the valve support 120 from the proximal capsule 384. The valvesupport 120 can self-expand into engagement with the downstream end ofanchoring member 110 to couple the two components together. The deliverycatheter 380 may then be withdrawn from the patient.

FIGS. 53A-53H show various mechanisms that may be used for coupling thevalve support 120 to the anchoring member 110 in the process shown inFIGS. 52A-52D. For example, as shown in FIG. 53A, the valve support 120may include a circumferential ridge or detent 388 near its downstreamend that engages in a groove 390 in the anchoring member 110 to inhibitdetachment of the two components. Alternatively, valve support 120 mayhave a hook 392 formed at the downstream end of each post 122 which isconfigured to extend around a downstream end of anchoring member 110,e.g. around either the downstream tip of rib 114 or connectors 116, asshown in FIGS. 53B-53C. For example, the hook 392 may be configured toflex inwardly when it engages the inner surface of the rib 114 as thevalve support 120 is advanced, and be configured to resiliently recoilto its outward configuration when extended beyond the downstream end ofthe rib 114, as shown in FIG. 53C. Optionally, a depth-limiting featuresuch as a stub 394 may extend outwardly from the valve support 120 whichis configured to engage a complementary feature such as a bump or ridge396 on the anchoring member 110 to prevent insertion of the valvesupport 120 beyond a predetermined depth.

In a further embodiment shown in FIGS. 53D-53F, the valve support 120may have a coupling element 398 on its outer surface configured toslideably couple to the anchoring member 110. In a first configuration,the coupling element 398 comprises a loop 400, shown in FIG. 53E,through which a vertical guide member 402 on the anchoring member 110may slide. The anchoring member 110 may have a plurality of such guidemembers 402 extending upwardly from its downstream end at locationsspaced around its circumference. A bump 404 may be formed near thedownstream end of each guide member 402 over which the loop 400 mayslide to inhibit the valve support 120 from sliding back in the upstreamdirection (FIG. 53D). In an alternative configuration, shown in FIG.53F, the guide member 402 has a vertical slot 406 into which a radiallyextending pin 408 on the valve support 120 can extend. The pin 408 mayslide to the downstream end of the slot 406 where it may be urgedthrough a waist 411, which prevents the pin 408 from sliding back in theupstream direction.

In a further embodiment shown in FIGS. 53G-53H, coupling elements 398 onthe valve support 120 are configured to slideably receive the ribs 114,which themselves perform a similar function as the guide members 402(described with respect to FIGS. 53D-53F). As shown in FIG. 53G,coupling of the ribs 114 to the valve support 120 helps restrain theribs 114 in a radially compact configuration when the valve support 120slides axially upward relative to the anchoring member 110. In thearrangement shown in FIGS. 53GG-53H, the delivery of the device 100 maynot require the need for a separate sheath to constrain the ribs 114during the delivery. As shown in FIG. 53H, the valve support 120 mayslide in the downstream direction relative to the anchoring member 110until the ribs 114 assume their radially outward configuration. As withguide members 402, each rib 114 may have a bump 412 formed near itsdownstream end past which coupling element 398 may be urged, but whichthen inhibits valve support 120 from sliding in the upstream direction(FIG. 53H).

FIGS. 54A-55C illustrate a delivery catheter 400 of a delivery system 40in accordance with additional embodiments of the present technology.FIG. 54A is a cross-sectional side view of the delivery system 40 forthe prosthetic heart valve device 100 and FIG. 54B is a partialcross-sectional side view of a distal portion of the delivery system 40shown in FIG. 54A. As shown in FIGS. 54A and 54B, the delivery catheter400 comprises a sheath 402 having an outer wall 403 and a closed distalnose 406 defining a blind annular cavity 408. An inner wall 405 extendsproximally to the proximal end of the catheter (not shown), thus forminga tubular catheter shaft 407 defining an inner lumen extending axiallytherethrough in which a guidewire GW may be slideably positioned. Apiston 412 is slideably disposed in the cavity 408 and has an O-ring 413around its circumference to create a fluid seal with the wall of thecavity 408. A tubular piston shaft 414 extends proximally from piston412 and is slideably mounted over the catheter shaft 407. The pistonshaft 414 is oversized relative to the catheter shaft 407 so as todefine a fluid lumen 416 which is in communication with the cavity 408.The device 26 is retained in its radially collapsed deliveryconfiguration within cavity 408, with piston shaft 414 and cathetershaft 407 extending through the interior of the valve support 120 (shownin FIGS. 55A-55C). Preferably, the device 100 is releasably coupled topiston 412 by, for example, pins (not shown) extending radiallyoutwardly from piston shaft 414.

The sheath 402 may have features that limit its travel. For example, awire (not shown) may tether the protective sheath to a handle on theproximal end of catheter 400. The wire may be attached to an adjustablestop on the handle, allowing the length of piston travel to be adjusted.When fluid is injected into cavity 408, piston 412 will travel untilthis stop is reached. In this manner, the deployment progression can becontrolled.

To ease the retraction of sheath 402 through the valve of the device 100following deployment, a tapered feature may advance to abut the proximalend of the sheath 402 (see FIG. 56). Alternatively, piston 412 may havea taper or soft bumper material affixed directly to the back of piston412 facing in the proximal direction. In this way the proximal side ofthe piston would itself provide an atraumatic leading surface to easeretraction of the sheath 402 through the valve support 120.

Features intended to control and smooth the deployment of device 100 canbe incorporated. For example, a common problem during deployment ofself-expanding stents is a tendency of the deployed device to “pop” orjump forward or backward as the final elements exit the deploymentdevice. Features to prevent the sheath 402 from being thrust forward bythe expanding skeletons of the device 100 may be important in order toprevent accidental damage to the ventricle or other tissue. Suchfeatures may incorporate stops or tethers within the deployment systemdesigned to retain the position of the sheath 402 relative to thedeployed device 100. For example, the proximal edge of the sheath 402could be swaged slightly inward to prevent the piston from exiting thesheath and to precisely locate the taper or bumper features describedabove to ease withdrawal of the system through the deployed valve.Alternatively or additionally, a spring mechanism (not shown) could bebuilt into the delivery system 40 so that when the last features of thedevice 100 leave the sheath 402, the sheath actively retracts slightlyinto the downstream end of the newly deployed device 100.

The operation of the delivery catheter 400 is illustrated in FIGS.55A-55C. The delivery catheter 400 is positioned at the target valvesite using one of the approaches described elsewhere herein. Thedelivery catheter 400 is particularly well suited to placement throughthe native valve from the upstream direction. The catheter 400 isadvanced until the sheath 402 is positioned downstream of the nativeannulus (FIG. 55A). Fluid can then be injected through fluid lumen 416into the cavity 408, distal to the piston 412 (FIG. 55B). This drivesthe sheath 402 distally, releasing the device 100 from the cavity 408(FIG. 55C). The delivery catheter 400 and the device 100 may remain in astationary longitudinal position relative to the native valve while thedevice 100 is deployed, thereby increasing the precision of deployment.In addition, the device 100 may be deployed in a slow and controlledmanner, avoiding sudden and uncontrolled jumps of the device 100.Further, such hydraulic actuation allows the sheath 402 to be moved inincremental steps to only partially deploy the device 100, allowing theoperator to assess its position relative to the native valve andreposition as needed before complete deployment.

In one embodiment, the piston 412 can be hydraulically actuated,however, in another embodiment, the piston 412 could be operated bymanual retraction of the piston shaft 414 or advancement of the sheath402. The delivery catheter 400 may be equipped with a handle on itsproximal end having a retraction mechanism coupled to the piston shaft414 and/or catheter shaft 407. Such a mechanism may use gears or pulleysto provide a mechanical advantage to reduce the force required toretract the piston or advance the sheath.

The delivery catheters in accordance with aspects of the presenttechnology may further be configured to be reversible, to allow thedevice 100 to be retracted back in to the catheter 400 after a full orpartial deployment. One embodiment of such a catheter is illustrated inFIG. 56, wherein the delivery catheter 400 of FIGS. 54A-55C is adaptedto retract the device 100 back into the sheath 402 after being fully orpartially deployed therefrom. The piston 412 has at least a first pulley420 coupled thereto, while distal nose 406 has at least a second pulley422 coupled thereto. A plurality of additional pulleys 423 may also beprovided at locations around the circumference of the piston 412 foradditional mechanical assistance. A cable 424, which may comprise alength of wire or suture, extends through the fluid lumen 416 and cavity408, passes around first and second pulleys 420, 422 and any additionalpulleys 423, and is secured to piston 412. The device 100 can bereleasably coupled to the piston shaft 414 by a plurality of pins 426extending radially from the piston shaft 414 into engagement with thedevice 100, preferably near a downstream end 428 thereof.

To deploy the device 100, the delivery catheter 400 of FIG. 56 operatessimilarly as described above in connection with FIGS. 55A-55C; however,in an additional embodiment and before the downstream end 428 has beenfully released from the sheath 402, the operator can checks the locationof the device 100. Upon deployment, the upstream end 430 of the device100 will expand toward its expanded configuration. An operator can view,using ultrasound, fluoroscopy, MRI, or other means, the position andshape of the deployed device 100 in the native tissue. Followingpositioning, the sheath 402 may be further advanced relative to thepiston 412 to fully deploy the device 100 from the sheath 402, whereuponthe downstream end 428 fully expands and pins 426 are disengaged fromdevice 100. In situations where the operator desires to recover thedevice 100 back into the sheath 402 for repositioning or other reasons,the cable 424 is pulled so as to move the piston 412 in the distaldirection relative to the sheath 402. The pins 426 pull the device 100with the piston 412 back into the sheath 402 and the device 100 iscollapsed as it is pulled in the sheath 402. The delivery catheter 400may then be repositioned and the device redeployed.

In one embodiment, the prosthetic heart valve device 100 may bespecifically designed for a specific approach or delivery method toreach the mitral valve, or in another embodiment, the device 100 may bedesigned to be interchangeable among the approaches or delivery methods.

Additional Embodiments of Prosthetic Heart Valve Devices, DeliverySystems and Methods

FIGS. 57A-57E are isometric views of prosthetic heart valve devices 600shown in an expanded configuration 602 and configured in accordance withadditional embodiments of the present technology. The prosthetic heartvalve devices 600 include features generally similar to the features ofthe prosthetic heart valve device 100 described above with reference toFIGS. 10A-56. For example, the prosthetic heart valve device 600includes the valve support 120 configured to support a prosthetic valve130 and an anchoring member 610 coupled to the valve support 120 in amanner that mechanically isolates the valve support 120 from forcesexerted upon the anchoring member 610 when implanted at the nativemitral valve. However, in the embodiments shown in FIGS. 57A-57E, anupstream region 612 of the anchoring member 610 is coupled to the valvesupport 120 such that a downstream region 611 of the anchoring member610 is configured to engage native tissue on or downstream of theannulus so as to prevent migration of the device 600 in the upstreamdirection.

FIGS. 57A and 57B illustrate embodiments of the device 600 wherein theanchoring member 610 includes a plurality of longitudinal ribs 614coupled to the upstream end 121 of the valve support 120 and extendingin a downstream to distal direction. As shown in FIG. 57A, the ribs 614can project radially outward away from the longitudinal axis 101 at thedownstream region 611 of the anchoring member 610 such that thedownstream region 611 is flared outward for engaging subannular tissuebelow the mitral annulus. FIG. 57B illustrates an embodiment of thedevice 600 having an anchoring member 610 with an upward-facing lip 617at the downstream region. In this embodiment, the ribs 614 can be formedsuch that the downstream region is generally flared outwardly from thelongitudinal axis 101 but the tips 615 of the ribs 614 reorient to pointin an upstream direction at the lip 617. The lip 617 may assist theanchoring member 610 in engaging subannular tissue and can be configuredto include tissue engaging elements (not shown) as described above withrespect to device 100. The anchoring member 610 can also be coupled tothe valve support 120 at a position desirable for positioning the valvesupport 120 and prosthetic valve 130 within the native valve. Forexample, FIG. 57C illustrates an embodiment of the device 600 in whichthe anchoring member 610 can be coupled to the valve support 120 at alocation downstream from the upstream end 121.

Referring to FIGS. 57A-57C together, the anchoring member 610 can have afirst cross-sectional dimension D_(C1) at the upstream region 612 thatis less than a second cross-sectional dimension D_(C2) at the downstreamregion 611. Additionally, the valve support 120 is radially separatedfrom the downstream region 611 of the anchoring member 610 such thatwhen the device 600 is deployed, the downstream region 611 can deforminwardly without deforming the upstream portion of the valve support120. Additionally, the anchoring member 610 can have a generally oval orD-shape, or other irregular shape such as those described above withrespect to FIGS. 16A-17C, while the valve support 120 can be generallycylindrical in shape. In such embodiments, the second cross-sectionaldimension D_(C2) can be greater than a corresponding cross-sectionaldimension (e.g., MVA1 or MVA2) of the annulus of the native mitral valve(FIG. 5C).

FIG. 57D illustrates yet another embodiment of the device 600 in anexpanded configuration 602. As shown, the valve support 120 can includea flange 620 at the downstream end 123 of the valve support 120. Theflange 620 can extend radially outward from the longitudinal axis 101 atthe downstream end 123 to radially engage subannular tissue. Theanchoring member 610 can include a plurality of ribs 614 coupled to theupstream end 121 of the valve support 120 and extending radially outwardin the downstream direction to attach to an outer rim 622 of the flange620. The anchoring member 610 can be configured to engage subannulartissue, such as inward-facing surfaces of the leaflets. In thisembodiment, the ribs 614 can be flexible such that deformation of theanchoring member 610 between the coupling at the upstream region 612 andthe coupling to the flange 620 at the lower region 611 will notsubstantially deform the valve support 120 wherein a prosthetic valve isconnected.

FIG. 57E is a schematic cross-sectional view of the prosthetic heartvalve device 600 of FIG. 57A implanted at a native mitral valve MV inaccordance with an embodiment of the present technology. As shown, theflared downstream region 611 of the anchoring member 610 can engage thesubannular tissue, e.g., inward-facing surfaces of the leaflets LF, asubannular surface, etc. The ribs 614 can incorporate tissue engagingelements 170 on the rib tips 615 for penetrating and/or partiallypenetrating the tissue. Further, the anchoring member 610 can expandradially outward to seal (not shown) against the tissue to preventmigration of the device 600 in the upstream or downstream directionand/or to prevent paravalvular leaks between the tissue and the device600. Accordingly, the device 600 can incorporate one or more sealingmembers 140 as described above with respect to device 100. Additionally,the device 600 can also include an atrial extension member or atrialretainer 410 (shown in dotted lines) as described above with respect tothe device 100. The atrial retainer, if present, can be configured toengage tissue above the annulus AN such as a supra-annular surface orsome other tissue in the left atrium LA to inhibit downstream migrationof the device (e.g., during atrial systole).

FIGS. 58A-58D are cross-sectional views of a heart showing a method ofdelivering a prosthetic heart valve device 600 to a native mitral valveMV in the heart using a trans-apical approach in accordance with anotherembodiment of the present technology. Referring to FIG. 58A, thedelivery catheter 18 is advanced through guiding catheter (not shown)which enters the left ventricle LV of the heart through a puncture inthe left ventricle wall at or near the apex of the heart and is sealedby a purse-string suture. Alternatively, the delivery catheter 18 may beplaced directly through a purse-string-sealed trans-apical incisionwithout a guiding catheter. The sheath 20, containing a collapsed device600, 606 (shown in FIG. 58B), is advanced through the mitral annulus ANbetween native leaflets LF as shown in FIG. 58A. Referring to FIGS.58B-58D together, the sheath 20 is pulled proximally to allow the device600 to expand to the expanded and/or deployed configurations 602, 604(FIGS. 58C and 58D).

Although the sheath 20 can be retracted and the device 600 allowed toexpand, the delivery system can remain connected to the device 600(e.g., system eyelets, not shown, are connected to the device eyelets,not shown) such that the operator can control the placement of thedevice 600 while in the expanded configuration 602 (FIGS. 58C and 58D).For example, as the sheath 20 is disengaged from the device 600, theupstream region 612 of the anchoring member 610 can remain collapsedwithin the sheath preventing the anchoring member 610 from fullyexpanding (FIG. 58C). During this phase of the delivery, the position ofthe device 600 within the mitral valve area can be adjusted or altered.After the device 600 is located at the target site, the sheath 20 can befully removed from the device 600 and the anchoring member 610 of thedevice 600 can expand outwardly at the downstream region 611 to engagesubannular tissue, such as the leaflets LF, and to retain the device 600in the desired target location. The pull-wires (not shown) may beretracted in a proximal direction to release the device 600 from thedelivery system, allowing the delivery system to be removed and thedevice to be fully implanted at the mitral valve MV in the deployedconfiguration 104. Alternatively, the device 600 may be expandedupstream or downstream of the desired target location then pulled orpushed downstream or upstream, respectively, into the target locationbefore releasing the device 600 from delivery system.

FIGS. 59A-59C are isometric views of prosthetic heart valve devices 700shown in an expanded configuration 702, and FIG. 59D is a schematiccross-sectional view of the prosthetic heart valve device 700 implantedat a native mitral valve configured in accordance with furtherembodiments of the present technology. The prosthetic heart valvedevices 700 include features generally similar to the features of theprosthetic heart valve devices 100 and 600 described above withreference to FIGS. 10A-58D. For example, the prosthetic heart valvedevice 700 includes the valve support 120 configured to support aprosthetic valve 130 and a first anchoring member 610 coupled to thevalve support 120 in a manner that mechanically isolates the valvesupport 120 from forces exerted upon the first anchoring member 610 whenimplanted at the native mitral valve. Particularly, the upstream region612 of the first anchoring member 610 is coupled to the valve support120 and the downstream region 611 of the first anchoring member 610 isconfigured to flare outwardly to engage native tissue on or downstreamof the annulus so as to prevent migration of the device 600 in theupstream direction. However, in the embodiments shown in FIGS. 59A-59D,the device 700 also includes a second anchoring member 710 having adownstream region 711 coupled to the valve support 120, and an upstreamregion 712 extending radially outward in the upstream direction.Accordingly, the device 700 includes both the first and second anchoringmembers 610 and 710 for engaging tissue on or under the annulus of themitral valve.

Referring to FIGS. 59A-59D together, the first anchoring member 610 canhave the first cross-sectional dimension D_(C1) at the upstream region612 that is less than the second cross-sectional dimension D_(C2) at thedownstream region 611. The second anchoring member 710 can have a thirdcross-sectional dimension D_(C3) at the upstream region 712 that isgreater than a fourth cross-sectional dimension D_(C4) at the downstreamregion 711. In some embodiments, the third cross-sectional dimensionD_(C3) is less than the second cross-sectional dimension D_(C2) suchthat the second anchoring member 710 can be partially surrounded by thefirst anchoring member 610 (FIG. 59A). In such an embodiment, theupstream region 712 can apply radial outward pressure against an innerwall (not shown) of the first anchoring member 610 and further supportthe fixation of the first anchoring member 610 to the tissue on or underthe annulus. In another embodiment shown in FIG. 59B, the thirdcross-sectional dimension D_(C3) can be approximately the same as thesecond cross-sectional dimension D_(C2) such that the first and secondanchoring members 610, 710 meet at a flared junction 740. In oneembodiment, the first and second anchoring members 610 and 710 can becoupled at the flared junction 740; however, in other embodiments, thefirst and second anchoring members 610 and 710 are not coupled. FIG. 59Cshows another embodiment of the device 700 wherein the downstream region615 of the first anchoring member 610 is separated from the upstreamregion 713 of the second anchoring member 710 by a gap 750. In oneembodiment, the device 700 shown in FIG. 59C can be implanted at thenative heart valve such that the first anchoring member 610 can engagesupra-annular tissue or other cardiac tissue upstream of the annulus andthe second anchoring member 710 can engage subannular tissue or othercardiac tissue downstream of the annulus such that the annulus isretained or captured within the gap 750.

In a further embodiment illustrated in FIG. 59D, the thirdcross-sectional dimension D_(C3) is greater than the secondcross-sectional dimension D_(C2) such that the second anchoring member710 can partially surround the first anchoring member 610. In such anembodiment, the downstream region 611 of the first anchoring member 610can apply radial outward pressure against an inner wall 741 of thesecond anchoring member 710 and further support the fixation of thesecond anchoring member 710 to the tissue on or under the annulus AN.

Additionally, the valve support 120 can be radially separated from thedownstream region 611 of the first anchoring member 610 as well as theupstream region 712 of the second anchoring member 710 such that whenthe device 700 is deployed, the downstream region 611 and/or theupstream region 712 can deform inwardly without substantially deformingthe valve support 120 or without deforming a support region 734 of thevalve support 120 supporting the prosthetic valve 130. Additionally, thefirst and second anchoring members 610, 710 can have a generally oval orD-shape, or other irregular shape such as those described above withrespect to FIGS. 16A-17C, while the valve support 120 can be generallycylindrical in shape. Moreover, additional features may be incorporatedon the device 700, such as sealing membranes 140 and tissue engagingelements 170 as described above with respect to the device 100.

FIGS. 60A-60B are cross-sectional side views of a distal end of adelivery catheter 18 for delivering the prosthetic heart valve device700 of FIG. 59C to a native mitral valve in the heart in accordance withanother embodiment of the present technology. As shown in FIGS. 60A-60Bthe prosthetic heart valve device 700 is collapsed into a deliveryconfiguration 706 and retained within a two portion delivery sheath 70at the distal end of the catheter 18 (FIG. 60A). Upon delivery of thedistal end of the catheter 18 to the desired location at or near anative mitral valve, the device 700 can be released from the two portionsheath 70 by retracting an upper portion 72 in a distal direction and/orretracting a lower portion 74 in a proximal direction (shown with arrowsin FIG. 60A) thereby separating the sheath and exposing the collapseddevice 700 from within the sheath 70. In one embodiment, the device 700can self-expand to its expanded configuration 702 following retractionof the sheath 70 (FIG. 60B). As illustrated in FIG. 60B, when the sheath70 is retracted in both the proximal and distal directions, the firstand second anchoring members 610, 710 can self-expand outwardly toengage the native tissue. When using a balloon 300 to expand the supportvalve 120, the balloon 300 can be inflated to fully expand the device700.

FIG. 61 illustrates a prosthetic heart valve device 800 configured inaccordance with another embodiment of the present technology. FIG. 61 isa side view of the device 800 that includes features generally similarto the features of the prosthetic heart valve devices 100, 600, 700described above with reference to FIGS. 10A-60B. For example, the device800 includes a support valve 120 having upstream and downstream ends121, 123 and an interior in which a valve (not shown) may be coupled.The device also includes first and second anchoring members 810 and 850.The first anchoring member 810 has a first flared upstream portion 812and a first downstream portion 811 that is coupled to an outer orexterior surface 127 of the valve support 120. The first flared upstreamportion 812 can be mechanically isolated from the valve support 120.Additionally, the first flared upstream portion 812 can be configured toengage supra-annular tissue of the native mitral valve. The secondanchoring member 850 can be configured to at least partially surroundthe first anchoring member 810 and to have a second flared upstreamportion 852 for engaging the subannular tissue of the native mitralvalve. The second anchoring member 850 can also have a second downstreamportion 851 coupled to the outer surface 127 of the valve support 120 ina manner that mechanically isolates the valve support 120 from at leastthe second upstream portion 852.

As shown in FIG. 61, the first anchoring member 810 can have a pluralityof first longitudinal ribs 814 and the second anchoring member 850 canhave a plurality of second longitudinal ribs 854. In one embodiment,each of the individual first ribs 814 are longer than each of theindividual second ribs 854 such that the first anchoring member 810 hasa height H_(AM1) greater than a height H_(AM2) of the second anchoringmember 850. Accordingly, the height H_(AM2) can be selected to orientthe second anchoring member 850 to engage subannular tissue, while theheight H_(AM1) can be selected to orient the first anchoring member 810to extend through the mitral valve from the left ventricle to engagesupra-annular tissue in the left atrium.

FIG. 61 illustrates one embodiment of the device 800 that can include alower ring 808 on which the ribs 814, 854 can be interconnected. Thelower ring 808 can allow the ribs 814, 854 to expand radially outwardaway from the valve support 120 at the upstream portions 812, 852. Thedevice 800 can also include a first upper ring member 816 coupled to theplurality of first longitudinal ribs 814. The first upper ring member816 can be shaped and or patterned to have a downward oriented rim 818for engaging supra-annular tissue. The device can further include asecond upper ring member 856 coupled to the plurality of secondlongitudinal ribs 854. The second upper ring member 856 can be shapedand or patterned to have an upward oriented rim 858 for engagingsubannular tissue.

FIGS. 62A-62C are partial cross-sectional side views of a distal end ofa delivery system 10 showing delivery of the prosthetic heart valvedevice 800 of FIG. 61 at a mitral valve MV in accordance with anotherembodiment of the present technology. The device 800 can be retained ina collapsed configuration 806 within a sheath 20 of the delivery system(FIG. 62A). When the distal end of the delivery system engages thetarget location, the sheath 20 can be retracted proximally from thedevice 800, thereby releasing the features of the device 800 to expandinto the expanded configuration 102 (FIGS. 62B-62C). As shown in FIG.62B, the second anchoring member 850 can be released first from theretracting sheath 20 and the upward oriented rim 858 of the second upperring member 856 can be positioned to engage the subannular tissue. Thesheath 20 can prevent the first anchoring member 810 from disengagingfrom the delivery system 10 and/or moving outside the sheath 20 untilthe rim 858 of the second anchoring member 850 is moved into position toengage the subannular tissue. Referring to FIG. 62C, a plunger 11 canengage the first anchoring member 810 (as shown by downward arrow inFIG. 62B) and/or the sheath 20 can be disengaged/retracted (shown byupward arrow in FIG. 62C) from the first anchoring member 810 therebyallowing the second anchoring member 850 to move radially outward to theexpanded configuration 802. The downward oriented rim 818 of the firstupper ring member 816 can be positioned to engage the supra-annulartissue (FIG. 62C). Once deployed, the rings 816, 856 can sandwich theannulus AN of the mitral valve and inhibit movement of the device 800 inboth upstream and downstream directions.

FIG. 63 is an isometric side view of a prosthetic heart valve device 900in accordance with a further embodiment of the present technology. Thedevice 900 includes features generally similar to the features of theprosthetic heart valve devices 100, 600, 700 and 800 described abovewith reference to FIGS. 10A-62C. For example, the device 900 includes asupport valve 120 having upstream and downstream ends 121, 123 and aninterior in which a valve (not shown) may be coupled. The device 900includes an anchoring member 910 that has a flared upstream portion 912and a downstream portion 911 coupled to the valve support 120. However,the device 900 also includes upper and lower rings 950, 952 and aplurality of flexible annulus engaging elements 970 distributed around acircumference 980 of the anchoring member 910 and configured to couplethe upper ring 950 to the lower ring 952. The flexible annulus engagingelements 970 can have a shape such as a C-shape or U-shape that isoriented to have an open portion outward from the device 900 such thatthe native annulus AN can be engaged in recesses 971 of the annulusengaging elements 970. The annulus engaging elements 970 can alsoinclude points 972, 973 for engaging and potentially piercingsupra-annular and subannular tissue, respectively. The annulus engagingelements 970 can be suitably flexible to bend in a manner that bringsthe points 972, 973 close together for securing the device 900 to theannulus AN when the device 900 is deployed.

FIGS. 64A-64B illustrate a method for deploying the device 900 at thenative mitral valve. Referring to FIGS. 63 and 64A-64B together, theannulus engaging elements 970 can be generally relaxed or have a widerecess 971 in an open state 903. As such, the upper ring 950 can restabove the lower ring 952 a first distance D_(R1) when the elements 970are in the open state 903. The device 900 can also include a pluralityof pull-wires 974 that are slideably engaged with the upper ring 950(e.g., through holes 975) and secured to the lower ring 952. When thewires 974 are pulled in an upward or upstream direction, the lower ring952 moves in an upward/upstream direction toward the upper ring 950. Asthe lower ring 952 approaches the upper ring 950, the annulus engagingelements 970 can bend such that the points 972, 973 are brought closertogether and/or engage or pierce the annulus tissue (FIG. 64B).Accordingly, when the device 900 is in the deployed state 904, the upperring 950 can be held by the pull-wires 974 at a second distance D_(R2)above the lower ring 952, wherein the second distance D_(R2) is lessthan the first distance D_(R1).

FIGS. 64C-64D show an alternative arrangement of the pull-wires 974 inwhich the wires 974 are secured to the upper ring 950 and are slideablyengaged with the lower ring 952 (e.g., through holes 976). Thepull-wires 974 can also be slideably engaged with the upper ring 950(e.g., such as through holes 975) such that the pull-wires can be pulledin an upward direction to bring the rings 950, 952 closer together inthe deployed state 904.

FIG. 65A is an isometric side view of a prosthetic heart valve device1000 in accordance with a further embodiment of the present technology.The device 1000 includes features generally similar to the features ofthe prosthetic heart valve devices 100, 600, 700, 800 and 900 describedabove with reference to FIGS. 10A-64D. For example, the device 1000includes a support valve 120 having upstream and downstream ends 121,123 and an interior 134 in which a valve 130 may be coupled. However,the device 1000 includes an inflatable anchoring member 1010 coupled toand at least partially surrounding the valve support 120. The inflatableanchoring member 1010 can be configured to inflate/expand upondeployment and engage native tissue at the desired target location. Asshown in FIG. 65A, the inflatable anchoring member 1010 can have one ormore fillable chambers 1014 for receiving a fill substance such as asolution (e.g., saline or other liquid) or gas (e.g., helium, CO₂ orother gas) following implantation of the device 1000. In otherembodiments, the fillable chambers 1014 can be filled with a hardeningmaterial (e.g., epoxy, cement, or other resin).

In one embodiment, the fillable chambers 1014 and/or the anchoringmember 1010 can be formed of polytetrafluoroethylene (PTFE), urethane,or other expandable polymer or biocompatible material. The fillablechambers 1014 can have a predetermined shape such that the fillablechambers 1014, when inflated, form fixation elements 1015 for engagingthe native anatomy. For example, the fixation elements 1015 can includea supra-annular flange 1016 for engaging a surface of the annulus ANwithin the left atrium LA. The elements 1015 may also include subannularflanges 1018 for engaging subannular tissue and/or arms 1020 forengaging leaflets LF (e.g., behind leaflets). Accordingly, the chambers1014 can be incorporated or shaped such that the anchoring member 1010engages supra-annular tissue, subannular tissue, leaflets or othertissue at or near the mitral valve MV while mechanically isolating thevalve support 120 from distorting diastolic and systolic forcesgenerated in the heart and particularly radial forces exerted on thedevice 1000 at or near the native mitral valve. For example, followingdeployment, the inflatable anchoring member 1010 can absorb pulsatileloading and other forces generated against the device 1000 such thatdeformation of the anchoring member 1010 does not substantially deformthe valve support 120.

FIG. 65B is a partial cross-sectional side view of a distal end of adelivery system 10 suitable for delivery of the prosthetic heart valvedevice 1000 of FIG. 65A in accordance with another embodiment of thepresent technology. As shown in FIG. 65B, the delivery system 10 caninclude a delivery catheter 18 configured to retain the device 1000 in acollapsed configuration 1006. In the collapsed configuration 1006, theinflatable anchoring member 1010 is deflated. The delivery system 10 canalso include a fill tube 90 suitable to deliver the fill substance whenthe device 1000 is in position and ready for deployment. Referring toFIGS. 65A-65B together, and in one embodiment, the inflatable anchoringmember 1010 can be partially filled with the fill substance such thatthe position of the device 1000 at the implant site can be adjusted toalign the fixation elements 1015 with the native tissue features beforefully expanding and/or inflating the anchoring member 1010 to hold thedevice 1000 in place at the target location.

FIGS. 66A-66D are cross-sectional views of prosthetic heart valvedevices 1100 having fillable chambers 1114 in accordance with additionalembodiments of the present technology. Similar to the device 1000discussed with respect to FIGS. 65A-65B, the devices 1100 includefeatures such as the valve support 120 having an interior 134 in which avalve 130 is coupled and include an expandable anchoring member 1110coupled to the valve support 120 in a manner that mechanically isolatesthe valve support 120 from forces exerted upon the anchoring member 1110when implanted at the native mitral valve. The anchoring member 1110 canbe coupled to the valve support 120 such that an upstream region 1112 ofthe anchoring member 1110 is configured to engage native tissue on ordownstream of the annulus so as to prevent migration of the device 1100in the upstream direction. In the embodiments shown in FIGS. 66A-66D,the devices 1100 can also include one or more fillable chambers 1114configured to expand and/or inflate in an outward direction to supportan outward expansion of the anchoring member 1100 (FIGS. 66A, 66C-66D),or to engage native tissue (FIG. 66B). In one embodiment, the fillablechambers 1114 and/or the anchoring member 1010 can be formed ofpolytetrafluoroethylene (PTFE), urethane, or other expandable polymer orbiocompatible material. The fillable chambers 1114 can have apredetermined shape such that the fillable chambers 1114, when inflated,form fixation elements for engaging the native anatomy (as shown in FIG.66B) or for engaging the anchoring member 1110 (as shown in FIGS. 66A,66C and 66D).

Referring to FIG. 66A, the fillable chamber 1114 can be chambers 1114created with a space between the valve support 120 and the anchoringmember 1110. Following expansion of the device 1100, the fillablechambers 1114 can be filled with a fill substance such as a solution(e.g., saline or other liquid) or gas (e.g., helium, CO₂ or other gas).In other embodiments, the fillable chambers 1114 can be filled with ahardening material (e.g., epoxy, cement, or other resin). In otherembodiments, the fillable chambers 1114 can be a separate component ofthe device 1100, such a ring-shaped chamber 1150 coupled to an outersurface 1142 of the anchoring member 1110 (FIG. 66B) or to an innersurface 1141 of the anchoring member 1110 or to an exterior surface 127of the support valve 120. In FIGS. 66C-66D, for example, the ring-shapedchamber 1150 can provide additional support to the anchoring member 1110such that inward deformation is counteracted by the presence of thering-shaped chamber 1150. Additionally, as shown in FIG. 66D, thefillable chamber 114 can be a ring-shaped chamber 1150 that deforms theanchoring member 1110 in an outward direction against the native tissue.

In accordance with another aspect of the present technology, FIGS.67A-67B illustrates other embodiments of a prosthetic heart valve device1200. Referring to FIGS. 67A-67B together, the device 1200 can include aradially expandable anchoring member 1210 configured to engage nativetissue on or downstream of the annulus, and a support valve 120 and/or aprosthetic valve 130 coupled to an interior portion 1234 of theanchoring member 1210. The anchoring member 1210 can have a firstlongitudinal length L_(L1) on a posterior leaflet-facing side 1222 ofthe anchoring member 1210 and have a second longitudinal length L_(L2)on an anterior leaflet-facing side 1224 of the anchoring member 1210. Asshown in FIG. 67A, the first length L_(L1) is greater than the secondlength L_(L2) such that occlusion of a left ventricle outflow tract(LVOT) is limited. Accordingly, in one embodiment, the posteriorleaflet-facing side 1222 can provide suitable fixation and support forthe anchoring member 1210 by engaging the thicker ventricular wall andtissue on the posterior leaflet side of the mitral valve. Concurrently,the shorter anterior leaflet-facing side 1224 of the anchoring member1210 can have sufficient sealing and conformability to engage theanterior leaflet and/or subannular tissue aligned with the anteriorleaflet of the native valve.

Optionally, the device 1200 can also include one or more stabilizingelements such as an arm 1250 coupled to the anchoring member 1210 forengaging a leaflet and/or a subannular surface. In FIG. 67A, the arm1250 can be coupled to a downstream end 1223 of the anchoring member1210 on the posterior leaflet-facing side 1222 of the anchoring member1210 and be configured to extend behind the posterior leaflet. In oneembodiment, the arm 1250 can be configured to sandwich the posteriorleaflet between the arm 1250 and the anchoring member 1210.

In FIG. 67B, the device 1200 can include first and second arms(individually identified as 1250 a and 1250 b) coupled to the anchoringmember 1210 for engaging leaflets and/or subannular surfaces. Forexample, the first arm 1250 a can be coupled to the downstream end 1223at the anterior leaflet-facing side 1224 of the anchoring member 1210with extension 1251 a and can be configured to further extend behind theanterior leaflet. The second arm 1250 b can be coupled to the downstreamend 1223 of the posterior leaflet-facing side 1222 of the anchoringmember 1210 with extension 1251 b and be configured to extend behind theposterior leaflet. In the illustrated embodiment, the extensions 1251 aand 1251 b can vary with respect to each other and be selected based onthe anatomy of the target tissue. In other embodiments, not shown, thearm 1250 and or the anchoring member 1210 can include tissue engagingelements as described above with respect to device 100 for furtherpositioning and stabilizing of the device 1200 at the desired targetlocation. One of ordinary skill will recognize that the valve support120 can also be uneven or have sides having different lengths such thatthe valve support will not substantially occlude the left ventricleoutflow tract (LVOT).

FIGS. 68A-68B are side views of prosthetic heart valve devices 1300shown in an expanded configuration 1302 and configured in accordancewith an additional embodiment of the present technology. The prostheticheart valve devices 1300 include features generally similar to thefeatures of the prosthetic heart valve device 100 described above withreference to FIGS. 10A-56. For example, the prosthetic heart valvedevice 1300 includes the valve support 120 configured to support aprosthetic valve 130 and an anchoring member 110 coupled to the valvesupport 120 in a manner that mechanically isolates the valve support 120from forces exerted upon the anchoring member 110 when implanted at thenative mitral valve. However, in the embodiments shown in FIGS. 68A-68B,the device 1300 also includes a positioning element 1350 configured toadjust or maintain a desired position of the device 1300 within or nearthe native mitral valve (e.g., away from the LVOT). The positioningelement 1350 can be coupled to the downstream portion 111 of theanchoring member 110 (as shown in FIGS. 68A-68B), the upstream portion112 of the anchoring member 110, or to the valve support 120, at anelement connection point 1352 and extend outward from the elementconnection point 1352 to engage ventricular tissue at a desiredlocation. In one embodiment, the positioning element 1350 can extendoutward from the device 1300 in a direction approximately transverse tothe longitudinal axis 101. In other embodiments, not shown, thepositioning element 1350 can extend outwardly from the device 1300 at anobtuse or an acute angle relative to the longitudinal axis 101 forengaging the ventricular tissue at the desired location.

In the embodiment shown in FIG. 68A, the positioning element 1350 caninclude a positioning arm 1354 and a tissue engaging portion 1356coupled to the distal arm end 1358 of the positioning arm 1354. Thepositioning arm 1354 and tissue engaging portion 1356 together canextend a desired positioning distance D_(P1) away from the elementconnection point 1352 on the device 1300 (e.g., from the anchoringmember 110) such that the distal end 1360 of the positioning element1350 can engage ventricular tissue, such as a ventricular wall. In someembodiments, the positioning distance D_(P1) can be selected to begreater than a distance between the implanted device 1300 and theventricular tissue such that the positioning element 1350, afterengaging the ventricular tissue, extends the distance between theimplant device 1300 and the ventricular tissue. In this way, the device1300 can be positioned, aligned and maintained in an alternate positionwithin or near the mitral valve.

The tissue engaging portion 1356 can be configured to contact theventricular tissue, or other tissue (e.g., annular tissue, leaflettissue, etc.), in an atraumatic manner such that the tissue engagingportion 1356 does not penetrate or pierce the tissue. In one embodiment,the tissue engaging portion 1356 can be resilient and/or be formed of ashape memory material (e.g., nitinol) that can be partially deformedwhen engaging tissue. For example, the tissue engaging portion 1356 canbe configured to absorb forces generated by the ventricular tissue(e.g., ventricular wall) during e.g., systole, without translatingmovement or altering a desired position of the device 1300 with respectto the native mitral valve. In other embodiments, the distal end 1360 ofthe positioning element 1350 can have other shapes or configurationsthat penetrate the ventricular tissue. The device 1300 can include oneor more positioning elements 1350 disposed around the device 1300 forpositioning and/or maintaining a desired position of the device 1300with respect to native anatomy. For example, it may be desirable toincrease the distance between the device 1300 and the left ventricularoutflow tract (LVOT), and a positioning element 1350 can be configuredto engage ventricular tissue to push or encourage the device 1300 aselected distance away from the LVOT.

In the embodiment shown in FIG. 68B, the positioning element 1350 caninclude a looped tissue engaging portion 1358 coupled to the device 1300at the connection point 1352. The looped tissue engaging portion 1358can extend the desired positioning distance D_(P1) away from the elementconnection point 1352 on the device 1300 (e.g., from the anchoringmember 110) such that the distal end 1360 of the looped tissue engagingportion 1358 can engage ventricular tissue, such as a ventricular wall.The looped tissue engaging portion 1358 can be configured to absorbradially contracting forces or other forces generated and transmitted bythe ventricular tissue (e.g., within the left ventricle) such that theyare not transmitted to or can change the position of the device 1300with respect to the native heart valve. Accordingly, the device 1300 canbe positioned, aligned and maintained in an alternate position within ornear the mitral valve.

In another embodiment, not shown, a positioning structure, separate fromthe prosthetic heart valve device 100, can be implanted or otherwisepositioned in the left ventricle (e.g., at or near the LVOT) and whichcan be configured to engage portions of the device 100, such as theanchoring member 110. Accordingly, such a positioning structure can beprovided to prevent the device 100 from obstructing or partiallyobstructing the LVOT. In one embodiment, not shown, the positioningstructure could be a stent-like cylinder or cage that expands intoengagement with the ventricular wall and keeps the LVOT clear to allowblood to flow freely from the left ventricle through the aortic valve.In one example, the positioning structure could be delivered by catheterthat is inserted through the aorta and the aortic valve into the leftventricle, or through the apex or the left atrium via the same deliverycatheter used for delivering and implanting the device 100.

FIGS. 69A-69E are cross-sectional and side views of prosthetic heartvalve devices 1400 shown in an expanded configuration 1402 andconfigured in accordance with an additional embodiment of the presenttechnology. The prosthetic heart valve devices 1400 include featuresgenerally similar to the features of the prosthetic heart valve devices100, 600 described above with reference to FIGS. 10A-57E. For example,the prosthetic heart valve devices 1400 include the valve support 120configured to support a prosthetic valve 130 and an anchoring member 110or 610 coupled to the valve support 120 in a manner that mechanicallyisolates the valve support 120 from forces exerted upon the anchoringmember 110 when implanted at the native mitral valve. However, in theembodiments shown in FIGS. 69A-69E, the devices 1400 also includes a anexpandable tissue-engaging ring 1450 coupled to a tissue engagingportion of the anchoring member 110 and configured to provide additionalcontact surface for engaging native tissue at or near the annulus of theheart valve.

In one embodiment, shown in FIGS. 69A-69B, the expandabletissue-engaging ring 1450 can be coupled to an upstream perimeter 113 ofthe anchoring member 110 and have a tissue-engaging surface 1452 facingin an outward direction relative to the device 1400. In someembodiments, the tissue-engaging surface 1452 can have tissue-engagingelements 170 for engaging and/or piercing the tissue. In anotherembodiment, shown in FIG. 69C, the expandable tissue-engaging ring 1450can be coupled to a downstream perimeter 115 of the anchoring member1410 and have a tissue-engaging surface 1452 facing in an outwarddirection relative to the device 1400. In another embodiment shown inFIG. 69D, the expandable tissue-engaging ring 1450 may include aplurality of fibrous elements 1454 (e.g., fiber elements) that can beconfigured to encourage tissue ingrowth, thrombus and/or be configuredto provide a seal between the anchoring member 110 and the tissue. Invarious arrangements, the expandable tissue-engaging ring 1450 canexpand and contract between various deployment and deliveryconfigurations.

FIG. 69E shows another embodiment of the prosthetic heart valve device1400 having the expandable tissue-engaging ring 1450. In thisembodiment, the device 1400 can have a valve support 120 coupled to afirst anchoring member 110 and a second anchoring member. In oneembodiment, the first anchoring member 110 can be coupled to the valvesupport 120 at the downstream end 123 and extends outward and in anupstream direction. The second anchoring member 1410 can be coupled tothe valve support 120 at the upstream end 121 and extend outward and ina downstream direction. The expandable tissue-engaging ring 1450 can becoupled to the distal portions of the first and second anchoring members110, 1410 and have the tissue-engaging surface 1452 facing in an outwarddirection relative to the device 1500 for engaging tissue at or near theannulus AN or leaflets LF. In a particular example, the expandabletissue-engaging ring 1450 can have a first end 1460 coupled to anupstream end 1461 of the first anchoring member 110. The expandabletissue-engaging ring 1450 can also have a second end 1470 coupled to adownstream end 1471 of the second anchoring member 1410. Thetissue-engaging surface 1452 may also include tissue engaging elements170 for engaging and/or piercing the tissue at the target location.

Referring to FIGS. 69A-69E together, the outward radial force of theexpandable tissue-engaging ring 1450 against the tissue and supported bythe anchoring members 110 and/or 1410 can prevent the device 1400 frommigrating in an upstream direction. Additionally, the expandabletissue-engaging ring 1450 along with at least the portions of theanchoring members 110 and/or 1410 that are uncoupled from the valvesupport 120 can effectively mechanically isolate the valve support 120and the valve 130 from compromising radially compressive forces exertedon the device 1400 from the heart valve tissue.

FIG. 70 is a cross-sectional side view of another prosthetic heart valvedevice 1500 configured in accordance with an embodiment of the presenttechnology. The device 1500 can also include features as described aboveincluding a valve support 120 and a prosthetic valve 130 retained withinthe valve support 120. The device 1500 can also include a plurality ofanchoring members (individually identified as 110 a-c). The anchoringmembers 110 a-c can be coupled at respective downstream perimeters 115a-c to the valve support 120 and be separated by gaps 1515 such thatrespective upstream perimeter 113 a-c can engage cardiac tissue atvariable target locations at the native valve. Optionally, the device1500 can also include the expandable tissue-engaging ring 1450 (FIGS.69A-D) such as those having tissue engaging features 170 for furtherengaging tissue at the native valve. In one embodiment, the expandabletissue-engaging ring 1450 can be coupled to the upstream perimeter ofmore than one anchoring member (e.g., the upstream perimeters 113 b and113 c of anchoring members 110 b and 110 c). However, in otherarrangements, the device 1500 will not have the expandabletissue-engaging ring 1450.

FIG. 71 is a cross-sectional side view of yet another prosthetic heartvalve device 1600 configured in accordance with an embodiment of thepresent technology. The device 1600 can also include features asdescribed above including a valve support 120 and a prosthetic valve 130retained within the valve support 120. The device 1500 can also includethe anchoring member 110. However, the device 1600 can also include anexpandable retainer 1610 for further engaging tissue at or near thenative valve annulus. In one embodiment, the retainer 1610 can be anextension of upstream end 121 of the valve support 120, however, inanother embodiment, the retainer 1610 can include a separate expandablefeature coupled to the upstream end 121 of the valve support. In somearrangements, the retainer 1610 can be mechanically isolated from thevalve support 120 such that forces generated at the native valve areabsorbed or otherwise translated by the retainer 1610. In this manner,the retainer 1610 may be deformed by radial forces exerted on theretainer 1610 while the valve support remains substantially undeformed.

In one embodiment, as shown, the anchoring member 110 can be configuredto engage the retainer 1610; however, in other embodiments, theanchoring member 110 can be positioned differently such that theanchoring member 110 contacts tissue different than that of the retainer1610. For example, the anchoring member 110 may extend outside a radius(not shown) of the retainer to contact subannular tissue. Additionaldetails and embodiments regarding the structure, delivery and attachmentof retainers 1610 suitable for use with the prosthetic heart valvedevices disclosed herein can be found in International PCT PatentApplication No. ______, (Attorney Docket NO. 82829-8005W000), entitled“DEVICES, SYSTEMS AND METHODS FOR HEART VALVE REPLACEMENT,” filed Oct.19, 2012, the entire contents of which are incorporated herein byreference.

ADDITIONAL EMBODIMENTS

Features of the prosthetic heart valve device components described aboveand illustrated in FIGS. 10A-71 can be modified to form additionalembodiments configured in accordance with the present technology. Forexample, the prosthetic heart valve device 1100 illustrated in FIGS.65A-65B without flared anchoring members can include anchoring membersthat are coupled to the valve support or other feature and areconfigured to extend radially outward to engage subannular tissue.Similarly, the prosthetic heart valve devices described above andillustrated in FIGS. 57A-71 can include features such as sealing membersas well as stabilizing features such as arms and tissue engagingelements.

Features of the prosthetic heart valve device components described abovealso can be interchanged to form additional embodiments of the presenttechnology. For example, the anchoring member 1210 of the prostheticheart valve device 1200 illustrated in FIG. 67A can be incorporated intothe prosthetic heart valve device 600 shown in FIGS. 57A-57C.

The following Examples are illustrative of several embodiments of thepresent technology.

Examples

1. A device for repair or replacement of a native valve of a heart, thenative valve having an annulus and leaflets coupled to the annulus,comprising:

-   -   an anchoring member having an upstream portion or a first        portion configured to engage with tissue on or under the annulus        and to deform in a non-circular shape to conform to the tissue        and a downstream portion or second portion; and    -   a valve support coupled to the downstream portion of the        anchoring member and configured to support a prosthetic valve,        wherein the valve support has a cross-sectional shape;    -   wherein the upstream portion of the anchoring member is        mechanically isolated from the valve support such that the        cross-sectional shape of the valve support remains sufficiently        stable that the prosthetic valve remains competent when the        anchoring member is deformed in the non-circular shape.

2. The device of example 1 wherein the valve support has an upstreamregion spaced radially inward from the upstream portion of the anchoringmember such that if the anchoring member is deformed inwardly theupstream region remains substantially undeformed.

3. The device of example 1 wherein the upstream portion is configured toengage valve tissue selected from an inward-facing surface of theannulus and an inward facing surface of the leaflets under the annulus.

4. The device of example 3 wherein the anchoring member is configured toapply outward force against the valve tissue so as to resist movement ofthe device when blood flows through the valve support in a downstreamdirection when the valve is open and when blood pushes in an upstreamdirection against the valve when the valve is closed.

5. The device of example 1 wherein the anchoring member isself-expanding.

6. The device of example 5 wherein the anchoring member comprisesNitinol.

7. The device of example 5 wherein the valve support is self-expanding.

8. The device of example 1 wherein both the anchoring member and thevalve support comprise a metal.

9. The device of example 1 wherein the anchoring member is formed of anitinol tube having a wall thickness of approximately 0.010 inches toabout 0.130 inches.

10. The device of example 1 wherein the anchoring member includes aplurality of longitudinal ribs having axial stiffness to resist movementof the device in an upstream direction.

11. The device of example 1 wherein the anchoring member includes aplurality of interconnected struts.

12. The device of example 11 wherein the plurality of interconnectedstruts are arranged in a diamond configuration.

13. The device of example 1 wherein the anchoring member comprises aplurality of wires.

14. The device of example 13 wherein the plurality of wires are wovenand/or welded together.

15. The device of example 1 wherein the anchoring member includes aplurality of flexible filaments arranged in a diamond configurationaround a circumference of the anchoring member, and wherein the diamondconfiguration includes one or more rows of diamonds and betweenapproximately 12 and approximately 36 columns of diamonds around thecircumference.

16. The device of example 1 wherein the valve support includes anupstream end and a downstream end, and wherein the upstream end extendsa distance in an upstream direction beyond the upstream portion of theanchoring member.

17. The device of example 1 wherein the valve support includes anupstream end and a downstream end, and wherein the upstream portion ofthe anchoring member extends a distance in an upstream direction beyondthe upstream end of the valve support.

18. The device of example 1 wherein the anchoring member includes a rimat a proximal end of the upstream portion, the rim having an undeformedconfiguration, the undeformed configuration having a generally ovalshape or a D-shape

19. The device of example 14 wherein the rim includes a plurality ofpeaks and a plurality of valleys.

20. The device of example 1 wherein:

-   -   the anchoring member includes a rim at a proximal end of the        upstream portion, the rim having a generally oval shape or        D-shape; and    -   the anchoring member includes a downstream end, and wherein a        distance between the downstream end and the rim varies around a        circumference of the anchoring member.

21. The device of example 20 wherein the distance varies from about 6 mmto about 20 mm.

22. The device of example 20 wherein the distance varies from about 9 mmto about 12 mm

23. The device of example 20 wherein the distance includes a pluralityof distances including:

-   -   a first distance between the downstream end and the rim being        approximately 7 mm to about 8 mm at first and second regions of        the anchoring member, first and second regions configured to        align with first and second commissures of the native mitral        valve;    -   a second distance between the downstream end and the rim being        approximately 9 mm to about 11 mm at a third region of the        anchoring member, the third region configured to align with an        anterior leaflet of the native mitral valve; and    -   a third distance between the downstream end and the rim being        approximately 12 mm to about 13 mm at a fourth region of the        anchoring member opposite the third region, the fourth region        configured to align with a posterior leaflet of the native        mitral valve.

24. The device of example 1 wherein:

-   -   the anchoring member includes a rim at a proximal end of the        upstream portion, the rim having a generally oval shape or        D-shape;    -   the tissue on or under the annulus has a non-circular shape        having a minor diameter and a major diameter generally        perpendicular to the minor diameter;    -   the upstream portion of the anchoring member has an outer        perimeter having a major perimeter diameter and a minor        perimeter diameter generally perpendicular to    -   the major perimeter diameter;    -   the major perimeter diameter is greater than the major diameter;        and the minor perimeter diameter is greater than the minor        diameter.

25. The device of example 24 wherein the major perimeter diameter isapproximately 2 mm to approximately 22 mm greater than the majordiameter.

26. The device of example 24 wherein the major perimeter diameter isapproximately 8 mm to approximately 15 mm greater than the majordiameter.

27. The device of example 24 wherein the major perimeter diameter isapproximately 45 mm to about 60 mm.

28. The device of example 24 wherein the minor perimeter diameter isapproximately 40 mm to about 55 mm.

29. The device of example 1 wherein the valve support is a generallycircular cylinder.

30. The device of example 29 wherein the valve support has a diameter ofapproximately 25 mm to about 30 mm.

31. The device of example 1 wherein the valve support is a cylindricalvalve support having a diameter of approximately 27 mm.

32. The device of example 1 wherein the valve support is a cylindricalvalve support having a longitudinal height of approximately 14 mm toabout 17 mm.

33. The device of example 1 wherein:

-   -   the upstream portion of the anchoring member has a proximal end        perimeter having peak portions and valley portions corresponding        to native peak and valley portions of the annulus, respectively;        and    -   the corresponding peak portions are configured to align with the        native valley portion and the corresponding valley portions are        configured to align with the native peak portions.

34. The device of example 1 wherein the valve support is extends arounda longitudinal axis, and wherein the upstream portion of the anchoringmember flares outward from the longitudinal axis by a taper angle.

35. The device of example 34 wherein the taper angle continuouslychanges between the downstream portion and the upstream portion.

36. The device of example 34 wherein the taper angle varies around acircumference of the upstream portion.

37. The device of example 34 wherein the taper angle is betweenapproximately 30° to about 75°.

38. The device of example 34 wherein the taper angle is betweenapproximately 40° to about 60°.

39. The device of example 1 wherein the valve support is oriented alonga first longitudinal axis and the anchoring member is oriented along asecond longitudinal axis, and wherein the first and second longitudinalaxes are non-collinear.

40. The device of example 39 wherein the second longitudinal axis isoff-set from the first longitudinal axis.

41. The device of example 39 wherein the second longitudinal axis isnon-parallel to the first longitudinal axis.

42. The device of example 41 wherein the second longitudinal axis isdisposed at an angle between 15° and 45° relative to the firstlongitudinal axis.

43. The device of example 1 wherein the upstream portion of theanchoring member includes a flared portion and a vertical portion, thevertical portion configured to radially expand and engage the annulus.

44. The device of example 43 wherein the flared portion includes tissueengaging elements configured to engage subannular tissue.

45. The device of example 1 wherein the upstream portion is radiallyseparated from the valve support by a gap.

46. The device of example 45 wherein:

-   -   the anchoring member includes a rim at a proximal end of the        upstream portion, the rim having an oval shape;    -   the valve support is a cylindrical valve support at least        partially surrounded by the anchoring member; and    -   the gap varies around a circumference of the cylindrical valve        support.

47. The device of example 46 wherein the gap is greater on an anteriorleaflet facing side of the device than on a posterior leaflet-facingside of the device.

48. The device of example 1 wherein the device is configured so as toavoid obstruction of a left ventricular outflow tract (LVOT) of theheart.

49. The device of example 1, further comprising a skirt overlying asurface of the anchoring member, the skirt configured to inhibit bloodflow between the anchoring member and the valve support.

50. The device of example 49 wherein the skirt is further configured toinhibit blood flow between the anchoring member and the tissue.

51. The device of example 49 wherein the skirt comprises at least one ofDacron®, ePTFE, bovine pericardium, a polymer, thermoplastic polymer,polyester, Gore-Tex®, a synthetic fiber, a natural fiber or polyethyleneterephthalate (PET).

52. The device of example 1 wherein the valve support is coupled to theanchoring member with one or more of a plurality of rivets and aplurality of sutures.

53. The device of example 1 wherein the valve support has a radialstrength of approximately 42 mm Hg to about 47 mm Hg.

54. The device of example 1 wherein the valve support has a radialstrength at least 100% greater than a radial strength of the anchoringmember.

55. The device of example 1, further comprising a valve coupled to thevalve support to inhibit retrograde blood flow.

56. The device of example 55 wherein the valve is a tri-leaflet valve.

57. The device of example 55 wherein the valve comprises bovinepericardium.

58. The device of example 55 wherein the valve has a plurality ofcommissural attachment structures, the valve being coupled to the valvesupport at the commissural attachment structures.

59. The device of example 58 wherein the commissural attachmentstructures are permanently fixed to the valve support.

60. The device of example 58 wherein the commissural attachmentstructures are integral with an interior wall of the valve support.

61. The device of example 58 wherein the valve support has a firstheight and the commissural attachment structures have a second heightless than the first height.

62. The device of example 1, wherein the valve support is furtherconfigured to receive a replacement valve after the device is implantedat a native valve location.

63. The device of example 62 further comprising a temporary valvecoupled to the valve support.

64. The device of example 63 wherein the temporary valve is adapted tobe displaced against an inner wall of the valve support when thereplacement valve is received in the valve support.

65. The device of example 63 wherein the temporary valve comprises aremovable valve, and wherein the replacement valve is secured within thevalve support after the temporary valve has been removed.

66. A prosthetic heart valve device for implantation at a native mitralvalve, the native mitral valve having an annulus and leaflets,comprising:

-   -   an anchoring member positionable in a location between the        leaflets, wherein an upstream portion or first portion of the        anchoring member is expandable to a dimension larger than a        corresponding dimension of the annulus such that upstream        movement of the anchoring member is blocked by engagement of the        upstream portion with tissue on or near the annulus, and the        anchoring member has a downstream portion or a second portion;        and    -   a valve support coupled to the downstream portion of the        anchoring member, wherein the valve support is spaced radially        inward from at least the upstream portion of the anchoring        member, and wherein the valve support is configured to support a        prosthetic valve.

67. The device of example 66 wherein the valve support is mechanicallyisolated from at least the upstream portion of the anchoring member.

68. The device of example 66 wherein the upstream portion of theanchoring member has a first flexibility and the valve support has asecond flexibility less than the first flexibility such that if theupstream portion of the anchoring member is distorted the valve supportremains substantially undistorted.

69. The device of example 66 wherein the upstream region of the valvesupport is spaced radially inward from the upstream portion of theanchoring member such that if the anchoring member is deformed inwardlythe valve support is not engaged.

70. The device of example 66 wherein:

-   -   the anchoring member is defined by a structure separate from the        valve support;    -   the valve support is coupled to the anchoring member at the        downstream portion of the anchoring member; and    -   the downstream portion is longitudinally spaced apart from the        upstream portion.

71. The device of example 66, further comprising a plurality of flexiblecoupling mechanisms configured to flexibly couple the valve support tothe downstream portion of the anchoring member.

72. The device of example 71 wherein the flexible coupling mechanism caninclude at least one of a suture, a wire, or a flexible filament.

73. The device of example 71 wherein the flexible coupling mechanism caninclude at least one of a rivet, a screw, or a pin.

74. The device of example 66 wherein the device is moveable into aplurality of configurations including:

-   -   a first configuration in which the valve support and the        anchoring member are radially contracted;    -   a second configuration in which the valve support and the        anchoring member are radially expanded; and    -   a third configuration in which the anchoring member is engaged        with and at least partially deformed by tissue on or near the        annulus.

75. The device of clam 74 wherein the valve support has an expandedshape in the second configuration, and wherein the valve support remainssubstantially in the expanded shape in the third configuration.

76. The device of example 74 wherein the anchoring member assumes thesecond configuration in an unbiased condition.

77. The device of example 74 wherein the anchoring member is deformablefrom the second configuration to the third configuration.

78. The device of example 74 wherein the device in the firstconfiguration has a low profile configured for delivery through a guidecatheter positioned at or near the native mitral valve.

79. The device of example 76 wherein the upstream portion of theanchoring member has a first diameter in the second configuration, andwherein the first diameter spans at least the distance between nativecommissures of the native mitral valve.

80. The device of example 76 wherein the upstream portion of theanchoring member has a first diameter and the valve support has a seconddiameter in the second configuration, and wherein the first diameter isapproximately between 1.2 to 1.5 times the second diameter.

81. The device of example 66 wherein the upstream portion of theanchoring member has a first expanded diameter of approximately 28 mm toabout 80 mm.

82. The device of example 66 wherein the valve support has an expandeddiameter of approximately 25 mm to about 32 mm.

83. The device of example 66 wherein the downstream portion islongitudinally spaced apart from the upstream portion, and wherein theupstream portion has a first cross-sectional dimension and thedownstream portion has a second cross-sectional dimension less than thefirst cross-sectional dimension.

84. The device of example 66 wherein the upstream portion is configuredto engage an inward facing surface of the leaflets downstream of theannulus.

85. The device of example 66 wherein the anchoring member resistsupstream migration of the device without any element of the deviceextending behind the leaflets of the native mitral valve.

86. The device of example 66 wherein the device does not engagesupra-annular tissue or tissue upstream of the annulus.

87. The device of example 66, further comprising a sealing memberextending around the upstream portion of the anchoring member andconfigured to seal against the tissue on or downstream of the annulus toinhibit blood flow between the anchoring member and the tissue.

89. The device of example 87 wherein the sealing member promotes tissueingrowth into the sealing member.

89. The device of example 87 wherein the sealing member comprises one ormore of a polymer, thermoplastic polymer, a polyester, a syntheticfiber, a fiber, polyethylene terephthalate (PET), PTFE, Gore-Tex® orDacron®.

90. The device of example 87 wherein the sealing member includes aplurality of tissue engaging elements on an outer surface of the sealingmember.

91. The device of example 87 wherein the anchoring member has aplurality of points on an upstream end, and wherein the points areconfigured to penetrate tissue on or downstream of the annulus so as toprevent upstream movement of the device.

92. The device of example 91 wherein the anchoring member includes adelivery mechanism for transitioning the plurality of points from aretracted position to an engagement position, and wherein the engagementposition includes penetration of the annulus tissue with the points.

93. The device of example 66 further comprising a plurality of anchoringclips on an upstream end of the anchoring member, wherein the anchoringclips are configured to engage the annulus.

94. The device of example 66 wherein the anchoring member includes—

-   -   a plurality of longitudinal ribs; and    -   a plurality of circumferential connectors interconnecting the        plurality of ribs;    -   wherein the anchoring member is flared in a proximal direction        such that proximal ends of the ribs orient radially outward for        engaging tissue on or downstream of the annulus so as to prevent        migration of the device in an upstream direction.

95. The device of example 94 wherein the anchoring member has a centrallongitudinal axis, and wherein each individual rib has a plurality ofsegments having varying extension angles relative to the longitudinalaxis.

96. The device of example 94 wherein the plurality of longitudinal ribsincludes a first and second plurality of ribs, and wherein the firstplurality of ribs have a characteristic different than the secondplurality of ribs, the characteristic selected from the group of size,shape, stiffness, extension angle and the number of ribs within a givenarea of the anchoring member.

97. The device of example 94 wherein the longitudinal ribs are unevenlyspaced around an outer perimeter of the anchoring member.

98. The device of example 94 wherein the valve support includes aplurality of posts connected circumferentially by a plurality of struts,and wherein each individual longitudinal rib is integrally formed with acorresponding post on the valve support.

99. The device of example 98 wherein each of the plurality oflongitudinal ribs comprises a curved elbow portion integrally formedwith the corresponding posts, the elbow portion configured to urgeindividual ribs radially outward from an inward configuration to anoutward configuration.

100. The device of example 98, further comprising a tether coupling eachindividual rib with the corresponding post, wherein the tether isconfigured to limit an outward deflection of the rib when the rib is inan expanded configuration.

101. The device of example 98 wherein one or more individualcircumferential connectors include a looped connector head, and whereinone or more individual struts include a looped strut head, and whereinthe looped connector heads are coupled to the looped strut heads to forma flexible coupling mechanism.

102. The device of example 101 wherein the looped connector head ispassed through the looped strut head to form the flexible couplingmechanism.

103. The device of example 101 wherein one or more flexible filamentscouple the looped connector head to the looped strut head to form theflexible coupling mechanism.

104. The device of example 94 wherein the plurality of circumferentialconnectors include a plurality of bands extending around a circumferenceof the anchoring member, and wherein the bands are slideably coupled toeach individual rib.

105. The device of example 66 wherein the anchoring member includes aplurality of longitudinal ribs arranged in a crisscross pattern to forma diamond configuration, and wherein the anchoring member is flared in aproximal direction such that proximal ends of the ribs orient radiallyoutward for engaging tissue on or near the annulus so as to preventmigration of the device in an upstream direction.

106. The device of example 66 wherein the valve support is generallycylindrical and at least the upstream portion of the anchoring member isgenerally non-circular.

107. The device of example 106 wherein the upstream portion of theanchoring member is D-shaped.

108. The device of example 66 wherein the upstream portion has aproximal end having a rim, and wherein the rim does not lie in a singleplane.

109. The device of example 108 wherein the rim has an undulating shapewith peaks extending in an upstream direction and valleys extending in adownstream direction.

110. The device of example 109 wherein at least one peak has a differentshape or dimension than at least one other peak.

111. The device of example 109 wherein at least one peak, if invertedlongitudinally, has a different shape or dimension that at least onevalley.

112. The device of example 109 wherein the rim has two peaks which areseparated by two valleys.

113. The device of example 109 wherein the valleys are configured forpositioning along commissural regions of the annulus.

114. The device of example 109 wherein the peaks have apices configuredto be positioned near midpoint regions of the leaflets.

115. The device of example 66 wherein:

-   -   the annulus comprises native peak portions and native valley        portions;    -   the upstream portion of the anchoring member has a proximal end        perimeter having corresponding peak portions and corresponding        valley portion; and    -   the corresponding peak portions are configured to align with the        native valley portion and the corresponding valley portions are        configured to align with the native peak portions.

116. The device of example 66 wherein:

-   -   the upstream portion of the anchoring member has a        cross-sectional dimension greater than a corresponding        cross-sectional dimension of the annulus of the native mitral        valve; and    -   the valve support has a support cross-sectional dimension less        than the corresponding cross-sectional dimension of the annulus.

117. The device of example 66 wherein at least the upstream portion ismechanically isolated from the valve support.

118. The device of example 66 wherein the downstream portion issubstantially tubular, and wherein the upstream portion of the anchoringmember is deformable to a non-circular cross-section while the valvesupport remains substantially circular in cross-section.

119. The device of example 66 wherein:

-   -   the valve support includes a plurality of first struts        interconnected around a circumference of the valve support;    -   the anchoring member includes a plurality of second struts        interconnected around a circumference of the anchoring member;        and    -   the first struts are more rigid than the second struts.

120. The device of example 94 wherein the longitudinal ribs areconfigured to absorb distorting diastolic and systolic forces generatedin a heart having the native mitral valve.

121. The device of example 94 wherein the ribs and connectors are formedin a chevron configuration.

122. The device of example 119 wherein the plurality of second strutsare interconnected in a chevron configuration.

123. The device of example 94 wherein the plurality of second struts areinterconnected in a diamond configuration.

124. The device of example 119 wherein the posts and struts are formedin a chevron configuration.

125. The device of example 94 wherein the ribs and connectors are formedof a shape memory material.

126. The device of example 125 wherein the shape memory materialcomprises nitinol.

127. The device of example 94, further comprising a plurality of tissueengaging elements on at least one of the ribs or the circumferentialconnectors, wherein the tissue engaging elements are configured toengage tissue of the annulus or leaflets.

128. The device of example 119, further comprising a plurality of tissueengaging elements on at least the second struts, wherein the tissueengaging elements are configured to engage tissue of the annulus orleaflets.

129. The device of example 127 wherein the tissue engaging elements areone of barbs, hooks or spikes.

130. The device of example 127 wherein one or more tissue engagingelements are oriented in an upstream direction, the one or more tissueengaging elements configured to limit movement of the device in theupstream direction during ventricular systole.

131. The device of example 127 wherein one or more tissue engagingelements are oriented in a downstream direction, the one or more tissueengaging elements configured to limit movement of the device in thedownstream direction.

132. The device of example 127 wherein the tissue engaging elementshave:

-   -   a piercing configuration in which the tissue engaging elements        have a low profile for penetrating the tissue; and    -   a retaining configuration in which the tissue engaging elements        have an expanded profile for maintaining the tissue engaging        element within the tissue.

133. The device of example 132 wherein the tissue engaging elements areheld in the piercing configuration with one or more of a biodegradableglue or a biodegradable coating.

134. The device of example 132 wherein the tissue engaging elementsexpand to one of a diamond shape, an arrowhead shape or a helical shapewhen in the retaining configuration.

135. The device of example 66 wherein the anchoring member is coupled toa sleeve, and wherein the sleeve is configured to limit radial expansionof the anchoring member when the anchoring member is in an expandedconfiguration.

136. The device of example 135 wherein the sleeve includes an outerportion configured to cover the anchoring member and an inner portionconfigured to at least partially surround the valve support.

137. The device of example 136 wherein the sleeve includes a pluralityof horizontal septums extending between the outer portion and the innerportion of the sleeve.

138. The device of example 84 wherein each individual rib has aflexibility independent of the flexibility of other ribs.

139. The device of example 94 wherein each individual rib has variableflexibility along a length of the rib.

140. The device of example 66 wherein the upstream portion of theanchoring member conforms to a shape of the annulus of the native mitralvalve while in a deployed configuration.

141. A device for treating a native mitral valve having an annulus andleaflets, comprising:

-   -   an anchor having an upstream portion configured to engage an        upstream-facing surface of the leaflets downstream of the        annulus; and    -   a valve support at least partially within the anchor, wherein        the valve support is configured to support a prosthetic valve;    -   wherein the anchor is deformable to a non-circular cross-section        while the valve support remains substantially circular in        cross-section.

142. The device of example 141, further comprising a sleeve at leastpartially surrounding the valve support, wherein the sleeve provides afluid barrier.

143. The device of example 141, further comprising a sealing memberextending around the upstream portion of the anchor and configured toseal against at least the upstream-facing surface of the leaflets toinhibit blood flow between the anchor and the leaflets.

144. The device of example 143 wherein the sealing member furtherextends around the valve support, and wherein the sealing member isconfigured to inhibit blood flow in a space between the valve supportand the anchor.

145. The device of example 141 wherein the anchor has a downstreamportion longitudinally separated from the upstream portion, and whereinthe downstream portion is coupled to a downstream end of the valvesupport.

146. The device of example 145 wherein the upstream portion is notdirectly coupled to the valve support.

147. The device of example 141 wherein the valve support has an upstreamend and a downstream end oriented along a longitudinal axis, and whereinthe anchor is coupled to the valve support at an intermediate positionbetween the upstream and downstream ends.

148. The device of example 141, further comprising a plurality oftethers coupling the upstream portion of the anchor to the valvesupport, the tethers configured to limit radial expansion of theupstream portion.

150. A device for implantation at a native valve having an annulus andleaflets, comprising:

-   -   a hyperboloidic anchoring member having an upstream end        configured to engage an inward facing surface of the leaflets        downstream of the annulus and a downstream end, wherein the        upstream end has a different cross-sectional area than the        downstream end;    -   a valve support positioned in the anchoring member and        configured to support a prosthetic valve, wherein the valve        support is coupled to the anchoring member at a location spaced        substantially downstream from the upstream end and is uncoupled        to the anchoring member at the upstream end.

151. The device of example 150 wherein the anchoring member is formed ofa flexible and shape memory material formed in a diamond pattern andconfigured to self-expand radially outward.

152. The device of example 150 wherein the flared anchoring member hasthe shape of a two-sheet hyperboloid.

153. The device of example 150, further comprising an atrial retainerconfigured to engage supra-annular tissue such that downstream movementof the device is blocked by engagement of the atrial retainer with thesupra-annular tissue.

154. The device of example 153 wherein the atrial retainer includesoutward-facing extensions of the valve support.

155. The device of example 153 wherein the atrial retainer includesextensions of the anchoring member configured to pass through the nativevalve to engage the supra-annular tissue.

156. The device of example 150, further comprising a sealing memberdisposed on the anchoring member and the valve support, the sealingmember configured to block blood flow between the valve support and theanchoring member.

157. The device of example 156 wherein the sealing member surrounds anouter surface of the valve support and an inner surface of the anchoringmember.

158. The device of example 156 wherein the sealing member includes asleeve configured to cover at least a portion of the upstream end of theanchoring member and configured to seal against at least the inwardfacing surface of the leaflets to inhibit blood flow between theanchoring member and the leaflets.

159. The device of example 156 wherein the sealing member comprises aflexible and biocompatible material.

160. The device of example 159 wherein the material comprises one ormore of Dacron®, ePTFE, or bovine pericardium.

160. The device of example 150 wherein the upstream end is configuredwith a plurality of atraumatic nodes such that the upstream end resistspenetration of the inward facing surface of the leaflets downstream ofthe annulus.

170. The device of example 150 wherein the upstream end is configuredwith a plurality of atraumatic nodes, and wherein the atraumatic nodesare unevenly space circumferentially around the upstream end.

171. The device of example 170 wherein the anchoring member includes aposterior facing side and an anterior facing side, and wherein a firstatraumatic node configuration on the posterior facing side is differentthan a second atraumatic node configuration on the anterior facing side.

172. A prosthetic heart valve device for repair or replacement of anative heart valve of a patient, the heart valve having an annulus andleaflets, comprising:

-   -   an anchoring member having an upstream portion or a first        portion having a first cross-sectional dimension and a        downstream portion or a second portion having a second        cross-sectional dimension less than the first cross-sectional        dimension, wherein the upstream portion is configured to engage        cardiac tissue to retain the anchoring member in a fixed        longitudinal position relative to the annulus; and    -   a valve support coupled to the downstream portion of the        anchoring member and configured to support a prosthetic valve,        wherein the valve support is radially separated from the        upstream portion of the anchoring member such that the upstream        portion can deform inwardly without substantially deforming the        valve support.

173. The device of example 172 wherein the anchoring member is moveablefrom a collapsed configuration for delivery of the device throughvasculature of the patient to an expanded configuration for engagementof the cardiac tissue.

174. The device of example 172 wherein the valve support comprises aninterior sized to receive a balloon, and wherein the balloon expands thevalve support from a delivery configuration to an expandedconfiguration.

175. The device of example 172 wherein at least one of the anchoringmember or the valve support comprises one or more of a resilientmaterial, shape memory material, super elastic material, or a nickeltitanium alloy, and wherein the at least one of the valve support or theanchoring member is configured to self-expand from a deliveryconfiguration to an expanded configuration when released from aconstraint.

176. The device of example 172, further comprising one or morepositioning elements coupled to the anchoring member, the positioningelements configured to engage ventricular tissue to position the deviceaway from the left ventricle outflow tract (LVOT).

177. The device of example 176 wherein the position element comprises:

-   -   a positioning arm configured to extend from the anchoring member        to the ventricular tissue; and    -   a tissue engaging portion at a distal end of the positioning        arm, wherein the tissue engaging portion is configured to engage        the ventricular tissue atraumatically.

178. A device for implantation at a native valve having an annulus and aplurality of leaflets, the device comprising:

-   -   an anchoring member positionable between the leaflets and having        a plurality of tissue engaging elements on an upstream end        configured to engage cardiac tissue on or near the annulus so as        to prevent migration of the device in the upstream direction;        and    -   a valve support positioned within an interior of the anchoring        member and coupled to a downstream portion of the anchoring        member, wherein the valve support is radially separated from at        least an upstream portion of the anchoring member.

179. A device for repair or replacement of a native mitral valve havingan annulus and a pair of leaflets, the device comprising:

-   -   a support structure having an upper region, a lower region, and        an interior to retain a prosthetic valve; and    -   an anchoring member surrounding at least a portion of the        support structure, wherein the anchoring member is positionable        between the leaflets and has a plurality of interconnected        struts, an upper portion, and a lower portion;    -   wherein the upper portion of the anchoring member is flared        outwardly in a proximal direction and includes a plurality of        tissue engaging elements extending radially outward so as to        engage cardiac tissue on or near the annulus and inhibit        migration of the device in the upstream direction; and    -   wherein the lower region of the support structure is coupled to        the lower portion of the anchoring member, and wherein the lower        region of the support structure is mechanically isolated from at        least deformation of the flared upper portion of the anchoring        member.

180. The device of example 179 wherein the anchoring member has acentral longitudinal axis, and wherein the interconnected struts includean arcuate region extending outwardly away from the longitudinal axis.

181. The device of example 179 wherein the device further comprises aplurality of flexible coupling mechanisms configured to flexibly couplethe support structure to the anchoring member.

182. The device of example 181 wherein the flexible coupling mechanismcan include at least one of a suture, a wire, a flexible filament, arivet, a screw, or a pin.

182. The device of example 179 wherein the plurality of interconnectedstruts comprises a resilient material.

183. The device of example 179 wherein the anchoring member comprises amaterial sufficiently resilient to self-expand from an inwardconfiguration to an outward configuration when released from aconstrained condition.

184. The device of example 179 further comprising a covering extendingover the plurality of interconnected struts, the covering comprising amaterial to encourage tissue in-growth.

185. The device of example 179 wherein the covering comprises a skirtextending over at least a portion of the anchoring member.

186. A prosthetic heart valve device, comprising:

-   -   a cylindrical support having a longitudinal axis and an interior        along the longitudinal axis through which blood may flow; and    -   an anchor defined by a structure separate from the cylindrical        support, the anchor having a non-circular cross-section, wherein        the anchor has an outwardly flared upstream end configured to        engage subannular tissue of a mitral valve, and wherein the        anchor surrounds the cylindrical support and is coupled to the        cylindrical support at a downstream end opposite the upstream        end.

187. The device of example 186, further comprising a valve coupledwithin the interior of the support and configured to block blood flowthrough the support in an upstream direction and allow blood flowthrough the support in a downstream direction.

188. The device of example 186, further comprising a stabilizing memberextending outward from the downstream end of the anchor, the stabilizingmember configured to engage native tissue downstream of an annulus ofthe mitral valve.

189. The device of example 188 wherein the stabilizing member includes aplurality of arms extending from the downstream end, the arm configuredto engage one or more of the subannular tissue, native leaflets, or aventricular wall.

190. The device of example 189 wherein the arms extend behind the nativeleaflets.

191. The device of example 189 wherein each individual arm includes anarm body and a tip at a distal end of the arm body, the tip configuredto engage native tissue.

192. The device of example 191 wherein the tip exerts force on thenative tissue without penetrating the native tissue.

193. The device of example 191 wherein the tip includes a tissueengaging element for piercing through at least a portion of the nativetissue.

194. The device of example 193 wherein the tissue engaging elementincludes at least one of a spike and a barb.

195. The device of example 191 wherein each individual arm includes anarm body extending away from the longitudinal axis at a first angle, andwherein each arm also includes an arm extension extending away from thelongitudinal axis at a second angle greater than the first angle.

196. The device of example 186 wherein the anchor has a secondlongitudinal axis, and wherein the second longitudinal axis is off-setfrom the longitudinal axis of the cylindrical support.

197. A device for repair or replacement of a native valve having anannulus and a plurality of leaflets, the device comprising:

-   -   an expandable cylindrical support configured for placement        between the leaflets, the support having an upstream region or a        first region, a downstream region or a second region and an        interior in which a valve may be coupled; and    -   an anchoring structure having a first portion and a second        portion, wherein the second portion of the anchoring structure        is coupled to the downstream region of the cylindrical support,        and wherein the first portion of the anchoring structure extends        outwardly away from the second portion, the anchoring structure        having an upstream or first perimeter configured to engage        tissue on or near the annulus;    -   wherein the anchoring structure is mechanically isolated from        the cylindrical support such that a force exerted radially at or        near the upstream perimeter will not substantially alter a shape        of the cylindrical support.

198. The device of example 197 wherein the device is implantable at anative mitral valve.

199. The device of example 198 wherein the anchoring structure isconfigured to inhibit movement of the device in an upstream direction byengagement of the tissue on or near the annulus.

200. The device of example 197 wherein the expandable cylindricalsupport and the anchoring structure are moveable between a deliveryconfiguration for placement of the device in a lumen of a deliverycatheter, and an expanded configuration for placement within the nativevalve.

201. The device of example 197 wherein the upstream perimeter includes atissue engaging element configured to at least partially penetrate thetissue on or near the annulus.

202. The device of example 197, further comprising a second anchoringstructure coupled to the upstream region of the cylindrical support andextending outwardly, so as to engage at least one of the anchoringstructure or the tissue on or near the annulus.

203. The device of example 197, further comprising a second anchoringstructure coupled to the upstream perimeter, the second anchoringstructure extending outwardly in a downstream direction.

204. The device of any one of examples 202 or 203 wherein the secondanchoring structure is mechanically isolated from the cylindricalsupport.

205. A device to treat a heart mitral valve of a patient, the devicecomprising:

-   -   an inner frame having an outer surface and an inner surface, the        inner surface configured to support a prosthetic valve; and    -   an outer frame coupled to the inner frame, the outer frame        having an upper portion with a cross-sectional dimension greater        than a corresponding cross-sectional dimension of an annulus of        the mitral valve, wherein the upper portion is configured to        engage tissue at or below the annulus of the mitral valve and        prevent migration of the device in an upward direction during        ventricular systole, and wherein at least the upper portion is        mechanically isolated from the inner frame.

206. The device of example 205 wherein:

-   -   the inner frame comprises a longitudinal axis; and    -   the inner frame comprises a delivery configuration and an        expanded configuration, wherein the outer surface is further        from the longitudinal axis in the expanded configuration than in        the delivery configuration.

207. The device of example 205 wherein:

-   -   inner frame comprises a longitudinal axis;    -   the outer surface is separated from the longitudinal axis by a        first distance; and    -   the upper portion of the outer frame is separated from the        longitudinal axis by a second distance greater than the first        distance.

207. The device of example 205 wherein the outer frame is conical ortapered between the upper portion and a lower portion.

208. The device of example 205 wherein the inner frame has a firstlongitudinal length on a posterior leaflet-facing side and a secondlength on an anterior leaflet facing side, and wherein the first lengthis greater than the second length.

209. The device of example 208 wherein the posterior leaflet facing sidefurther includes an arm configured to receive a posterior leafletbetween the arm and the outer frame.

210. A prosthetic heart valve device for treating a native mitral valvehaving an annulus and a pair of leaflets, the device comprising:

-   -   a cylindrical inner skeleton having an interior to which a        prosthetic valve may be coupled;    -   an outer skeleton coupled to the inner skeleton and positionable        between the leaflets downstream of the annulus, the outer        skeleton having a plurality of interconnected struts, wherein at        least a portion of the struts are configured to engage native        subannular tissue so as to prevent migration of the device in an        upstream direction; and    -   wherein the outer skeleton is deformable to a non-circular        cross-section while the inner skeleton remains substantially        circular in cross-section.

211. The device of example 210 wherein each of the interconnected strutsare inclined away from the inner skeleton.

212. The device of example 210 wherein the outer skeleton has adownstream portion and an upstream portion, wherein the downstreamportion is coupled to the inner skeleton, and wherein the struts extendoutwardly at the upstream portion to engage native subannular tissue.

213. The device of example 210 wherein the outer skeleton has adownstream portion and an upstream portion, wherein the upstream portionis coupled to the inner skeleton, and wherein the struts extendoutwardly at the downstream portion to engage native subannular tissue.

214. The device of example 210 wherein each of the interconnected strutsprovides a column strength sufficient to inhibit movement of the devicerelative to the annulus under the force of systolic blood pressureagainst a valve mounted in the inner skeleton.

215. The device of example 210 wherein at least some of the strutsinclude upstream extensions configured to engage supra-annular tissue ina left atrium.

216. The device of example 210 wherein the inner skeleton includesatrial extending members to engage supra-annular tissue such thatdownstream movement of the device is blocked by the atrial extendingmembers.

217. The device of example 210 wherein the interconnected strutscomprise ribs interconnected by a plurality of circumferentialconnectors.

218. The device of example 210 wherein the interconnected struts arearranged in a diamond configuration.

219. A prosthetic mitral valve device, comprising

-   -   a valve support having upstream and downstream ends, an interior        in which a valve may be coupled, and a perimeter; and    -   an anchoring member having a flared upstream portion and a        downstream portion coupled to the perimeter of the valve        support, wherein the upstream portion is mechanically isolated        from the valve support and is configured to engage subannular        tissue of a native mitral valve;    -   wherein the device is moveable into a plurality of        configurations including:        -   a first configuration in which the valve support and the            anchoring member are radially contracted, and wherein the            valve support has a first cross-sectional shape;        -   a second configuration in which the valve support and the            anchoring member are radially expanded, and wherein the            valve support has a second cross-sectional shape; and        -   a third configuration in which the anchoring member is            engaged with and deformed by the subannular tissue while the            valve support remains in the second cross-sectional shape.

220. The device of example 219 wherein the upstream portion of theanchoring member is oval or D-shaped in the third configuration.

221. The device of example 219 wherein the upstream portion of theanchoring member is oval or D-shaped in the second configuration.

222. The device of example 219 wherein the upstream portion of theanchoring member provides a seal over native mitral valve commissures inthe third configuration.

223. The device of example 219 wherein the upstream portion of theanchoring member substantially conforms to the shape of the subannulartissue.

224. The device of example 219 wherein the upstream portion of theanchoring member is substantially circular in the second configuration.

225. The device of example 219 wherein the valve support issubstantially circular in cross-section in the third configuration.

226. The device of example 219 wherein the upstream portion of theanchoring member has a first dimension in the second configuration, thefirst dimension larger than a corresponding dimension of the subannulartissue such that the upstream portion is compressed to a seconddimension less than the first dimension and substantially the same asthe corresponding dimension when the device is in the thirdconfiguration.

227. The device of example 226 wherein the upstream portion remainsbiased toward expanding toward the first dimension such that theanchoring member provides radial outward force against the subannulartissue.

228. A device for treating a native mitral valve of a patient, thenative mitral valve having an annulus and a pair of leaflets, the devicecomprising:

-   -   an anchoring member positionable between the leaflets and having        a downstream end configured to engage native tissue on or        downstream of the annulus so as to prevent migration of the        device in the upstream direction; and    -   a valve support configured to support a prosthetic valve,        wherein the valve support is coupled to the anchoring member,        and wherein the valve support is mechanically isolated from the        anchoring member.

229. The device of example 228 wherein:

-   -   the anchoring member surrounds at least a portion of the support        structure;    -   the anchoring member has a plurality of flexible wires arranged        in a diamond pattern, wherein the anchoring member is flared in        a distal direction such that distal ends of the wires point        radially outward so as to engage native tissue on or near the        annulus and to inhibit migration of the device in the upstream        direction; and    -   the valve support is mechanically isolated from at least a        flared portion of the anchoring member.

230. The device of example 228 wherein the anchoring member has anupstream end having a first cross-sectional dimension and the downstreamend having a second cross-sectional dimension greater than the firstcross-sectional dimension, and wherein the downstream end is configuredto engage an inward facing surface of the leaflets downstream of theannulus.

231. The device of example 228 wherein the valve support is radiallyseparated from the downstream end of the anchoring member such that thedownstream end can deform inwardly without deforming the valve support.

232. The device of example 228 wherein:

-   -   the downstream end of the anchoring member is non-cylindrical;    -   the valve support is cylindrical and at least partially        surrounded by the anchoring member; and    -   the anchoring member is coupled to the valve support at an        upstream end opposite the downstream end.

233. The device of example 228 wherein the anchoring member has adownstream portion with a cross-sectional dimension greater than acorresponding cross-sectional dimension of the annulus of the nativemitral valve.

234. The device of example 228, further comprising a sealing memberextending around the downstream end of the anchoring member andconfigured to seal against the native tissue to inhibit blood flowbetween the anchoring member and the native tissue.

235. The device of example 228 wherein the valve support has a proximalend and a distal end, and wherein the anchoring member is coupled to thevalve support at a position intermediate the proximal and distal ends.

236. The device of example 228 wherein the valve support includes adownstream portion, and wherein the downstream portion includes anoutward extending flange configured to radially engage subannulartissue.

237. The device of example 228 wherein the downstream end is flared inan upstream direction.

238. The device of example 228, further comprising a second anchoringmember, the second anchoring member having a second upstream endconfigured to engage tissue on or downstream of the annulus and having asecond downstream end coupled to the valve support.

239. The device of example 228, further comprising tissue engagingelements on the anchoring member.

240. A device for implantation at a native mitral valve, the nativemitral valve having an annulus and leaflets, comprising:

-   -   a valve support having upstream and downstream ends, an interior        in which a valve may be coupled, and an outer surface;    -   a first anchoring member having a first flared upstream portion        and a first downstream portion coupled to the outer surface of        the valve support, the first upstream portion mechanically        isolated from the valve support and configured to engage        supra-annular tissue of the native mitral valve; and    -   a second anchoring member at least partially surrounding the        first anchoring member, the second anchoring member having a        second flared upstream portion and a second downstream portion        coupled to the outer surface of the valve support, wherein the        second upstream portion is mechanically isolated from the valve        support and is configured to engage subannular tissue of the        native mitral valve.

241. The device of example 240 wherein:

-   -   the first anchoring member has a plurality of first flexible        filaments arranged in a diamond configuration, wherein at least        a portion of the first filaments are configured to engage native        supra-annular tissue so as to prevent migration of the device in        the downstream direction; and    -   the second anchoring member has a plurality of second flexible        filaments arranged in the diamond configuration, wherein at        least a portion of the second filaments are configured to engage        native subannular tissue so as to prevent migration of the        device in the upstream direction.

242. The device of example 241 wherein the first anchoring member has afirst height and the second anchoring member has a second pluralityheight, and wherein the first height is different than the secondheight.

243. The device of example 240 wherein the first upstream portionincludes a first ring member for engaging the supra-annular tissue, andwherein the second upstream portion includes a second ring member forengaging the subannular tissue.

exampleexample 244. A device for implantation at a native mitral valve,the native mitral valve having an annulus and leaflets, comprising:

-   -   a valve support having upstream and downstream ends, an interior        in which a valve may be coupled, and an outer surface; and    -   an expandable fixation element coupled to the outer surface,        wherein the fixation element is configured to engage tissue        above, on and below the annulus;    -   wherein the fixation element includes one or more inflatable        chambers coupled to and mechanically isolated from the outer        surface of the valve support between the upstream and downstream        ends.

245. The device of example 244 wherein the inflatable chambers arefilled with saline.

246. The device of example 244 wherein the inflatable chambers arefilled with gas.

247. The device of example 244 wherein the inflatable chambers areformed of Polytetrafluoroethylene (PTFE) or urethane.

248. The device of example 244 wherein the inflatable chambers form aU-shaped structure for engaging the annulus and the leaflets.

249. A device for implantation at a native mitral valve, the nativemitral valve having an annulus and leaflets, comprising:

-   -   a radially expandable valve support configured to engage native        tissue on or downstream of the annulus, wherein the valve        support has a first longitudinal length on a posterior        leaflet-facing side and a second length on an anterior leaflet        facing side; and    -   a valve coupled to an interior of the valve support;    -   wherein the first length is greater than the second length such        that occlusion of a left ventricle outflow tract (LVOT) is        limited.

250. The device of example 249 wherein the posterior leaflet facing sidefurther includes an arm configured to receive a posterior leafletbetween the arm and the valve support.

251. A device for implantation at a native mitral valve, the nativemitral valve having an annulus and leaflets, comprising:

-   -   a valve support having upstream and downstream ends, an interior        in which a valve may be coupled, and an outer surface; and    -   an anchoring member having a flared upstream portion and a        downstream portion coupled to the outer surface of the valve        support, wherein the upstream portion has an upper ring and a        lower ring coupled to the upper ring; and    -   a plurality of flexible coupling elements coupling the upper        ring to the lower ring and configured to draw the lower and        upper rings together;    -   wherein the lower ring is configured to move in an upstream        direction toward the upper ring such that the annulus is        received between the upper and lower rings.

252. The device of example 251 wherein the anchoring member ismechanically isolated from the valve support.

253. The device of example 251 wherein the lower ring is moved in anupstream direction with wires attached to the lower ring.

254. A method for replacement of a native heart valve having an annulusand leaflets coupled to the annulus, the method comprising:

-   -   positioning a prosthetic device between the leaflets in a        collapsed configuration;    -   allowing the prosthetic device to expand such that an anchoring        member of the prosthetic device is in a subannular position in        which it engages tissue on or downstream of the annulus, the        anchoring member having a diameter larger than a corresponding        diameter of the annulus in the subannular position; and    -   allowing a valve support to expand within the anchoring member,        wherein the valve support is coupled to the anchoring member,        the valve support having a support region configured to support        a prosthetic valve;    -   wherein the support region of valve support is mechanically        isolated from the anchoring member such that deformation of the        anchoring member when engaging the tissue does not substantially        deform the support region.

255. The method of example 254 wherein the prosthetic device comprisesthe device of any one of examples 1-140, 150-178, 219-227 and 251-253.

256. The method of example 254, further comprising delivering theprosthetic device by catheter prior to positioning the prosthetic devicebetween the leaflets.

257. The method of example 256, further comprising retracting a sheathon the catheter to expose the prosethetic device in an expandedconfiguration, and moving the prosthetic device in an upstream directionsuch that the upstream portion of the anchoring member engages tissue.

258. The method of example 256, further comprising navigating thecatheter configured to retain the prosthetic device in a deliveryconfiguration by one or more of a trans-septal approach from a rightatrium, a trans-apical approach via a left ventricular incision orpuncture, or a trans-aortic approach through the aorta.

259. A method of treating a mitral valve of a patient, the mitral valvehaving an annulus and leaflets, the method comprising:

-   -   implanting a device within or adjacent to the annulus, the        device comprising a valve support and an anchoring member        coupled to and at least partially surrounding the valve support,        wherein the anchoring member is disposed between the leaflets,        and wherein an upstream portion of the anchoring member engages        tissue on or downstream of the annulus to prevent migration of        the device in an upstream direction; and    -   wherein the valve support has a support region for supporting a        prosthetic valve, and the support region is mechanically        isolated from the anchoring member at least at the upstream        portion such that deformation of the upstream portion does not        substantially deform the support region.

260. The method of example 259, wherein the implanting step includes:

-   -   positioning the device between the leaflets and downstream of        the annulus when the device is in a delivery configuration;    -   expanding the device from the delivery configuration to an        expanded configuration with the anchoring member extending        between the leaflets; and    -   moving the device in an upstream direction to engage the tissue        on or downstream of the annulus with the upstream portion.

261. The method of example 259 wherein the upstream portion of theanchoring member has an oval shape when in a deployed configuration andthe tissue at or below the annulus has a corresponding oval shape, andwherein the method further comprises:

-   -   viewing the anchoring member and the mitral valve with        echocardiography or fluoroscopy; and    -   aligning the upstream portion of the anchoring member to engage        with the tissue on or downstream of the annulus based on the        echocardiography or fluoroscopy.

262. The method of example 259 wherein the prosthetic valve is coupledto the valve support, and wherein the prosthetic valve configured toallow blood to flow from a left atrium to a left ventricle and toinhibit blood flow from the left ventricle to the left atrium.

263. The method of example 262 wherein the anchoring member inhibitsmovement of the device toward the left atrium by engaging subannulartissue when the left ventricle contracts and the valve inhibits bloodflow from the left ventricle to the left atrium.

264. The method of example 259, further comprising delivering the deviceby catheter prior to implantation at the mitral valve.

265. The method of example 259, further comprising retracting a sheathon the catheter to expose the device in an expanded configuration, andmoving the device in an upstream direction such that the upstreamportion of the anchoring member engages subannular tissue.

266. The method of example 259, further comprising navigating a catheterconfigured to retain the device in a delivery configuration by one ormore of a trans-septal approach from a right atrium, a trans-apicalapproach via a left ventricular incision or puncture, or a trans-aorticapproach through the aorta.

267. The method of example 259 wherein a temporary valve coupled to thevalve support is activated after the device is implanted.

268. The method of example 267, further comprising positioning areplacement valve in an interior of the valve support and expanding thereplacement valve into engagement with the valve support after thedevice has been implanted.

269. The method of example 259, further comprising coupling theprosthetic valve to the valve support after the device has beenimplanted at the mitral valve.

270. The method of example 259 wherein the device further comprises theprosthetic valve mounted to the support region of the valve supportbefore the device is implanted.

271. The method of example 270 wherein prosthetic valve comprises atissue valve.

272. The method of example 270 wherein the prosthetic valve comprises aplurality of leaflets which coapt to block blood flow through the valvesupport in the upstream direction.

273. The method of example 272 wherein the support region ismechanically isolated from the anchor member such that when the upstreamportion is deformed in a non-circular shape the leaflets remain coaptedsufficiently to block blood flow.

274. The method of example 259 wherein the anchor member has a pluralityof tissue engaging elements around the upstream portion, and wherein themethod further comprises engaging the tissue with the tissue engagingelements.

275. The method of example 274 wherein the engaging the tissue comprisespenetrating the tissue with the tissue engaging elements.

276. The method of example 259, further comprising sealing blood flowpaths between the anchor member and the tissue.

277. The method of example 276 wherein sealing blood flow pathscomprises positioning a flexible sealing member between the anchormember and the tissue.

278. The method of example 277 wherein the flexible sealing membercomprises a skirt extending around a circumference of the anchor member.

279. The method of example 278 wherein the skirt is configured to blockblood flow between the anchor member and the support member.

280. The method of example 259, further comprising inhibiting downstreammovement of the device relative to the annulus of the mitral valve.

281. The method of example 280 wherein inhibiting downstream movement ofthe device relative to the annulus of the mitral valve comprisesengaging supra-annular tissue with an atrial element coupled to thedevice.

282. The method of example 280 wherein inhibiting downstream movement ofthe device relative to the annulus of the mitral valve comprisespenetrating tissue on or near the annulus with a plurality of tissueengaging elements coupled to the anchor member.

283. The method of example 282, further comprising penetrating thetissue with the tissue engaging elements, wherein the tissue engagingelements comprise retention elements configured to resist pull-out fromthe tissue after penetration.

284. The method of example 283 wherein penetrating the tissue with thetissue engaging elements comprises:

-   -   inserting the retention elements into the tissue in a compact        configuration; and    -   allowing the retention elements to expand into an expanded        configuration after penetration of the tissue.

285. The method of example 260 wherein expanding the device from thedelivery configuration comprises allowing the valve support toresiliently self-expand from a collapsed configuration to a deployedconfiguration.

286. The method of example 260 wherein expanding the device from thedelivery configuration comprises allowing the anchor member toresiliently self-expand from a delivery configuration to an expandedconfiguration.

287. The method of example 259, further comprising radially expandingthe valve support after the anchoring member engages the tissue on ordownstream of the annulus.

288. The method of example 259 wherein the device is the device of anyone of examples 1-140, 150-178, 219-227 and 251-253.

289. The method of example 259 wherein implanting a device within oradjacent to the annulus includes moving the device through a pluralityof configurations including:

-   -   a first configuration in which the valve support and the        anchoring member are radially contracted, and wherein the valve        support has a first cross-sectional shape;    -   a second configuration in which the valve support and the        anchoring member are radially expanded and the valve support has        a second cross-sectional shape greater than the first        cross-sectional shape; and    -   a third configuration in which the anchoring member is engaged        with and at least partially deformed by tissue on or downstream        of the annulus while the valve support remains in the second        cross-sectional shape.

290. The method of example 259, further comprising engaging one or morestabilizing members coupled to the anchoring member with native tissue.

291. A system for replacing a native valve in a patient, the systemcomprising:

-   -   an elongated catheter body having a distal end and a proximal        end;    -   a housing coupled to the distal end of the catheter body and        having a closed end and an open end;    -   a plunger within the housing axially movable relative thereto;    -   an actuator at the proximal end of the catheter body and coupled        to the plunger such that moving the actuator moves the housing        axially relative to the plunger; and    -   a prosthetic valve device having a collapsed configuration and        an expanded configuration, wherein the prosthetic valve device        is positionable in the housing in the collapsed configuration        and is releasable proximally from the housing by moving the        actuator.

292. The system of example 291 wherein the prosthetic valve devicecomprises the device of any one of examples 1-253.

293. A system to treat a mitral valve of a patient, the mitral valvehaving an annulus, the system comprising:

-   -   a device comprising the device of any one of examples 1-253; and    -   a catheter having a lumen configured to retain the device        therein.

294. The system of example 293, further comprising a replacement valveconfigured to couple to the device after placement of the device at anative mitral valve location.

295. The system of example 294, further comprising a delivery cathetercoupled to the replacement valve.

296. The system of example 293 wherein the catheter comprises anexpandable member configured to radially expand portions of the device.

297. The system of example 293 wherein the catheter comprises aretractable sheath and the device is contained within the sheath, andwherein the device is configured to resiliently expand when the sheathis retracted.

298. The system of example 293 wherein the catheter comprises aguidewire lumen adapted to slideably receive a guidewire, the guidewirelumen having proximal and distal ports through which the guidewire maybe slideably inserted.

CONCLUSION

The above detailed descriptions of embodiments of the technology are notintended to be exhaustive or to limit the technology to the precise formdisclosed above. Although specific embodiments of, and examples for, thetechnology are described above for illustrative purposes, variousequivalent modifications are possible within the scope of the technologyas those skilled in the relevant art will recognize. For example, whilesteps are presented in a given order, alternative embodiments mayperform steps in a different order. The various embodiments describedherein may also be combined to provide further embodiments.

From the foregoing, it will be appreciated that specific embodiments ofthe technology have been described herein for purposes of illustration,but well-known structures and functions have not been shown or describedin detail to avoid unnecessarily obscuring the description of theembodiments of the technology. Where the context permits, singular orplural terms may also include the plural or singular term, respectively.

Moreover, unless the word “or” is expressly limited to mean only asingle item exclusive from the other items in reference to a list of twoor more items, then the use of “or” in such a list is to be interpretedas including (a) any single item in the list, (b) all of the items inthe list, or (c) any combination of the items in the list. Additionally,the term “comprising” is used throughout to mean including at least therecited feature(s) such that any greater number of the same featureand/or additional types of other features are not precluded. It willalso be appreciated that specific embodiments have been described hereinfor purposes of illustration, but that various modifications may be madewithout deviating from the technology. Further, while advantagesassociated with certain embodiments of the technology have beendescribed in the context of those embodiments, other embodiments mayalso exhibit such advantages, and not all embodiments need necessarilyexhibit such advantages to fall within the scope of the technology.Accordingly, the disclosure and associated technology can encompassother embodiments not expressly shown or described herein.

1-162. (canceled)
 163. A device for treatment of a native mitral valveof a heart, the device comprising: an anchoring member having anupstream portion, wherein the anchoring member comprises a first frame;a sealing member extending around the upstream portion of the anchoringmember, wherein the sealing member is configured to extend over anatrial side of a native annulus, and wherein the anchoring member andthe sealing member are configured to prevent paravalvular leaks betweenthe device and native tissue; an inner valve support disposed in theanchoring member, wherein the inner valve support comprises a secondframe; and a prosthetic valve carried by the inner valve support. 164.The device of claim 163 wherein the anchoring member comprises aplurality of ribs, and wherein each rib comprises: a lower rib segment;and an upper rib segment extending from the lower rib segment, whereinthe upper rib segment is angled radially outward from a longitudinalaxis of the device.
 165. The device of claim 164 wherein the sealingmember comprises a first portion disposed on the upper rib segments ofthe anchoring member and a second portion disposed on the lower ribsegments of the anchoring member.
 166. The device of claim 164 wherein:the lower rib segment is angled radially outwardly from a downstreamportion of the inner valve support in an upstream direction; the lowerrib segment is angled radially outward at a first angle from thelongitudinal axis; and the upper rib segment is angled radially outwardfrom the longitudinal axis at a second angle greater than the firstangle.
 167. The device of claim 163 wherein the anchoring member furthercomprises an atrial retainer configured to extend radially outward toengage a supra-annular surface.
 168. The device of claim 163 wherein theanchoring member and the inner valve support are spaced apart by a gap,and wherein the sealing member is disposed across the gap between theanchoring member to the inner valve support.
 169. The device of claim163 wherein the anchoring member has a first diameter at the upstreamportion and a second diameter smaller than the first diameter at adownstream portion of the anchoring member.
 170. The device of claim 163wherein the sealing member is on an inner surface of the anchoringmember.
 171. The device of claim 163 wherein the sealing member is acontinuous sleeve of material extending around the anchoring member.172. The device of claim 163 wherein the anchoring member and the innervalve support are coupled together at a downstream portion of the devicevia a filament.
 173. The device of claim 163 wherein the anchoringmember and the inner valve support are coupled together at a downstreamportion of the device via a fastener.
 174. The device of claim 163wherein: the anchoring member comprises circumferential connectors at adownstream portion of the device; the inner valve support comprisesstruts at the downstream portion; and the circumferential connectors andthe struts couple together to attach the anchoring member to the innervalve support at the downstream portion.
 175. The device of claim 163wherein: the valve support comprises a tubular member made of fabricpolymer, or pericardium with no metallic structural support; and theprosthetic valve comprises leaflets attached to the tubular member. 176.The device of claim 175 wherein the sealing member comprises a sleevethat extends around the anchoring member, and wherein the tubular memberis attached to the sleeve.
 177. The device of claim 175 wherein thetubular member comprises a plurality of struts embedded within a wall ofthe tubular member.
 178. A device for treatment of a native mitral valveof a heart, the device comprising: an outer frame having a first portionand a second portion downstream of the first portion with respect toblood flow through the native mitral valve; an atrial retainer around acircumference of the first portion of the outer frame, wherein theatrial retainer is configured to extend over an atrial side of a nativeannulus and engage a supra-annular surface; a sealing member on theouter frame; an inner frame at least partially within the outer frame;and a prosthetic valve carried by the inner frame.
 179. The device ofclaim 178 wherein the sealing member interconnects the outer frame tothe inner frame.
 180. The device of claim 178 wherein the sealing memberextends around an inner wall of the outer frame.
 181. The device ofclaim 178 wherein the sealing member comprises a first portion thatextends completely around the outer frame and a second portion on theatrial retainer.
 182. The device of claim 178 wherein the sealing memberis attached to the prosthetic valve.
 183. The device of claim 178,further comprising a tubular member made of fabric with no metallicstructural support, wherein the tubular member is attached to the innerframe, and wherein the prosthetic valve comprises leaflets attached tothe tubular member.
 184. The device of claim 183 wherein the sealingmember comprises a sleeve that extends around the outer frame, andwherein the tubular member is attached to the sleeve.
 185. The device ofclaim 178, further comprising a tubular member made of fabric, polymer,or pericardium, wherein the tubular member is attached to the innerframe, and wherein the inner frame comprises a plurality of strutsembedded within a wall of the tubular member.
 186. The device of claim178 wherein the outer frame comprises a plurality of ribs arrangedaround a circumference of the outer frame to form a diamond pattern.187. The device of claim 178 wherein the atrial retainer is integrallyformed with the outer frame.
 188. The device of claim 176 wherein theouter frame comprises a plurality of longitudinal ribs and wherein theribs continue beyond the outer frame in an upstream direction to formthe atrial retainer.
 189. A device for treatment of a native mitralvalve of a heart, the device comprising: an outer frame having aplurality of struts; a plurality of flexible annulus engaging elementsextending outwardly from the outer frame from locations along acircumference of the outer frame; a sealing member coupled to the outerframe; an inner frame having a plurality of struts, wherein at least aportion of the inner frame is within the outer frame; and a prostheticvalve carried by the inner frame.
 190. The device of claim 189 whereinthe plurality of flexible annulus engaging elements define an atrialretainer that is configured to extend over an atrial side of a nativeannulus to engage a supra-annular surface.
 191. The device of claim 189,further comprising a tubular member attached to the inner frame,wherein: the tubular member is made of fabric; the prosthetic valvecomprises leaflets attached to the tubular member; and the sealingmember coupled to the outer frame is attached to the tubular member.192. The device of claim 189 wherein the sealing member comprises asleeve extending around the outer frame and a tubular member connectedto the inner frame, wherein the tubular member and the sleeve areattached together.